attachment b n-nitrosodimethylamine (ndma) analysis ......11 3.944 rbb 0.039 1 3.928 3.968...

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Confidential Information: This information should not be reproduced without written approval from Valisure LLC. ATTACHMENT B N-Nitrosodimethylamine (NDMA) Analysis Data for Native and Treated Ranitidine by GC/MS-Headspace Prepared by Kaury Kucera, Ph.D, Chief Scientific Officer of Valisure Updated: 30 July 2019 Referenced Data from Valisure GC/MS results GCMS Date ran Sequence name File Name 150 mg Tablets or equivalent Lot # NDMA per tablet above control (ng) 1 EX_G CMS 20190 309 20190309_RANITIDIN E_pH_Check 06101 011 Reference Powder (8.51 mg used) LRAB 9973 (A=12561 9) 140274.9 /8.51 mg *150 mg =247253 1 2 EX_GC MS 20190 409 20190409_RANITIDIN E_SUTDY_RUN_1 00801 008 Zantac, Brand OTC 18M4 98M (A=22603 71) 2834798 3 EX_GC MS 20190 409 20190409_RANITIDIN E_SUTDY_RUN_1 00401 004 Zantac (mint), Brand OTC 18H5 46 (A=25514 59) 2847110 4 EX_GC MS 20190 409 20190409_RANITIDIN E_SUTDY_RUN_1 00601 006 Wal-Zan, Walgreens 79L8 0081 9A (A=21996 71) 2444046 5 EX_GC MS 20190 409 20190409_RANITIDIN E_SUTDY_RUN_1 01001 010 Wal-Zan (mint), Walgreens 8ME2 640 (A=23715 89) 2635006 6 EX_GC MS 20190 413 20190413_RANITIDIN E_STUDY_OTC_RUN_2 02801 028 Ranitidine, CVS 9BE2 773 (A=22683 31) 2520311 7 EX_GC MS 20190 413 20190413_RANITIDIN E_STUDY_OTC_RUN_2 02601 026 Zantac (mint), CVS 9AE2 864 (A=29414 36) 3267968 8 EX_GC MS 20190 409 20190409_RANITIDIN E_SUTDY_RUN_1 01201 012 Ranitidine, Equate 9BE2 772 (A=22319 24) 2479872

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  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    ATTACHMENT B

    N-Nitrosodimethylamine (NDMA) Analysis Data for Native and Treated Ranitidine by GC/MS-Headspace

    Prepared by Kaury Kucera, Ph.D, Chief Scientific Officer of Valisure

    Updated: 30 July 2019

    Referenced Data from Valisure GC/MS results

    GCMS Date ran

    Sequence name File Name

    150 mg Tablets or equivalent

    Lot # NDMA per tablet above control (ng)

    1 EX_GCMS

    20190309

    20190309_RANITIDINE_pH_Check

    06101011

    Reference Powder (8.51 mg used)

    LRAB9973

    (A=125619) 140274.9 /8.51 mg *150 mg =2472531

    2 EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    00801008

    Zantac, Brand OTC

    18M498M

    (A=2260371) 2834798

    3 EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    00401004

    Zantac (mint), Brand OTC

    18H546

    (A=2551459) 2847110

    4 EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    00601006

    Wal-Zan, Walgreens

    79L800819A

    (A=2199671) 2444046

    5 EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    01001010

    Wal-Zan (mint), Walgreens

    8ME2640

    (A=2371589) 2635006

    6 EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    02801028

    Ranitidine, CVS 9BE2773

    (A=2268331) 2520311

    7 EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    02601026

    Zantac (mint), CVS

    9AE2864

    (A=2941436) 3267968

    8 EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    01201012

    Ranitidine, Equate

    9BE2772

    (A=2231924) 2479872

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    9 EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    02401024

    Ranitidine (mint), Equate

    8ME2642

    (A=2524866) 2805259

    10

    EX_GCMS

    20190409

    20190409_RANITIDINE_SUTDY_RUN_1

    01601016

    Ranitidine, Strides

    77024060A

    (A=2656658) 2951649

    1.

    Ion 74.00 (73.70 to 74.70): 06101011.D\data.ms NMP_11.8+Ranitidine_Ref

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.317 rVB 0.059 4 3.312 3.371 2 3.408 rBB 0.075 10 3.376 3.451 3 3.622 rBB 0.032 2 3.601 3.633 4 3.638 rBB 0.037 2 3.633 3.67 5 3.713 rBV 0.016 1 3.708 3.724 6 3.772 rVB 0.064 22 3.74 3.804 7 3.906 rBB 0.048 5 3.884 3.933 8 4.109 rVB 0.043 5 4.098 4.141 9 4.248 rBV 0.107 32 4.2 4.307 10 4.329 rVV 0.054 72 4.307 4.361 11 4.371 rVV 0.032 5 4.361 4.393 12 4.398 rVB 0.027 2 4.393 4.42 13 4.569 rVB 0.064 8 4.548 4.612 14 4.644 rBB 0.059 3 4.612 4.671 15 4.682 rBV 0.032 3 4.671 4.703 16 4.719 rBB 0.037 1 4.709 4.746 17 4.778 rBV 0.016 1 4.768 4.784 18 4.933 rBB 0.075 4 4.891 4.966 19 5.137 rBV 0.08 16 5.094 5.174 20 5.222 rBV 0.343 125619 5.174 5.517 21 5.549 rVB 0.102 279 5.522 5.624

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    22 5.795 rVB 0.048 10 5.784 5.833 23 5.993 rBV 0.091 33 5.972 6.063 24 6.866 rVB 0.054 14 6.844 6.898 25 7.09 rBV 0.054 15 7.064 7.117 26 7.139 rVB 0.059 13 7.122 7.181 27 7.465 rVB 0.032 2 7.46 7.492 28 7.513 rVB 0.08 6 7.502 7.583 29 7.615 rVB 0.043 5 7.599 7.642 30 7.647 rBB 0.016 1 7.642 7.658 31 7.765 rBB 0.021 1 7.754 7.775 32 8.311 rBV 0.161 458 8.193 8.353 33 8.519 rBV 0.209 1530 8.412 8.621 34 10.971 rBV 0.091 226 10.944 11.035 35 13.411 rVB 0.102 136 13.385 13.486

    2.

    Ion 74.00 (73.70 to 74.70): 00801008.D\data.ms ZANTAC_3

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.134 rBV 0.031 3 3.126 3.158 2 3.213 rVB 0.039 4 3.205 3.244 3 3.252 rBB 0.031 2 3.244 3.275 4 3.307 rVB 0.063 5 3.283 3.346 5 3.354 rVB 0.031 3 3.346 3.378 6 3.386 rBV 0.024 2 3.378 3.401 7 3.511 rBB 0.11 8 3.449 3.559 8 3.59 rBV 0.055 4 3.559 3.614 9 3.795 rBB 0.087 4 3.74 3.826 10 3.85 rBB 0.055 6 3.826 3.881 11 3.944 rBB 0.039 1 3.928 3.968

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    12 3.999 rVB 0.118 81 3.976 4.094 13 4.101 rBV 0.024 2 4.094 4.117 14 4.196 rBB 0.063 5 4.172 4.235 15 4.353 rBV 0.189 33 4.243 4.432 16 4.487 rBB 0.063 7 4.463 4.526 17 4.573 rBV 0.031 3 4.566 4.597 18 4.668 rBB 0.047 5 4.652 4.699 19 4.833 rBV 0.142 34 4.754 4.896 20 4.912 rVB 0.039 3 4.904 4.943 21 4.975 rBV 0.039 3 4.943 4.982 22 5.077 rBV 0.031 2 5.061 5.093 23 5.329 rBV 0.362 2260371 5.266 5.627 24 5.651 rVB 0.244 5036 5.627 5.871 25 7.216 rBV 0.149 351 7.177 7.327 26 8.396 rBV 0.189 742 8.302 8.491 27 8.593 rBV 0.142 465 8.538 8.679 28 9.199 rVB 0.189 320 9.167 9.356 29 11.094 rBV 0.079 112 11.063 11.142 30 12.62 rVB 0.079 107 12.589 12.668 31 13.517 rBV 0.189 782 13.478 13.667 32 14.084 rBV 0.118 301 14.044 14.162

    3.

    Ion 74.00 (73.70 to 74.70): 00401004.D\data.ms ZANTAC_MINT_1

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.299 rBB 0.071 3 3.283 3.354 2 3.378 rVB 0.039 2 3.37 3.409 3 3.441 rBB 0.039 1 3.433 3.472 4 3.496 rBB 0.063 5 3.472 3.535 5 3.59 rVB 0.031 4 3.575 3.606

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    6 3.795 rBB 0.063 16 3.763 3.826 7 3.858 rBB 0.071 5 3.826 3.897 8 3.999 rVB 0.079 77 3.968 4.046 9 4.07 rBV 0.039 3 4.046 4.086 10 4.149 rVB 0.047 3 4.133 4.18 11 4.204 rBB 0.071 7 4.18 4.251 12 4.361 rBV 0.118 32 4.306 4.424 13 4.487 rBB 0.024 1 4.479 4.503 14 4.518 rVB 0.071 8 4.511 4.581 15 4.589 rBV 0.024 2 4.581 4.605 16 4.668 rBB 0.071 8 4.636 4.707 17 4.833 rBB 0.165 41 4.762 4.927 18 5.022 rBB 0.102 9 4.967 5.069 19 5.101 rBB 0.102 6 5.093 5.195 20 5.234 rBV 0.039 3 5.203 5.242 21 5.329 rBV 0.354 2551459 5.274 5.628 22 5.651 rVB 0.244 3738 5.628 5.871 23 7.217 rBV 0.228 487 7.169 7.397 24 7.799 rBB 0.087 23 7.775 7.862 25 8.444 rBV 0.197 831 8.326 8.522 26 8.577 rVV 0.142 519 8.546 8.687 27 11.095 rBV 0.11 176 11.071 11.181 28 13.525 rBV 0.087 164 13.494 13.58 29 14.084 rVB 0.236 709 14.044 14.28

    4.

    Ion 74.00 (73.70 to 74.70): 00601006.D\data.ms WAL_ZAN_2

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.22 rBB 0.063 8 3.189 3.252 2 3.401 rBB 0.079 2 3.394 3.472 3 3.496 rVB 0.055 5 3.48 3.535 4 3.59 rBV 0.063 5 3.559 3.622

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    5 3.63 rVB 0.039 2 3.622 3.661 6 3.677 rBB 0.047 3 3.661 3.708 7 3.74 rBB 0.024 1 3.732 3.755 8 3.763 rBB 0.039 2 3.755 3.795 9 3.834 rBV 0.102 8 3.818 3.921 10 3.999 rBB 0.071 70 3.968 4.039 11 4.109 rVB 0.024 1 4.094 4.117 12 4.188 rBB 0.063 6 4.164 4.227 13 4.345 rBV 0.11 19 4.298 4.408 14 4.455 rVB 0.087 24 4.408 4.495 15 4.518 rBB 0.047 3 4.495 4.542 16 4.668 rBB 0.087 10 4.621 4.707 17 4.747 rBB 0.031 1 4.739 4.77 18 4.833 rBV 0.102 30 4.77 4.872 19 4.967 rBV 0.047 3 4.935 4.982 20 5.045 rVB 0.071 7 5.014 5.085 21 5.124 rBV 0.055 4 5.085 5.14 22 5.226 rBB 0.039 2 5.218 5.258 23 5.329 rBV 0.37 2199671 5.258 5.628 24 5.651 rVV 0.244 4991 5.628 5.871 25 5.895 rVB 0.362 1378 5.871 6.233 26 7.216 rBV 0.173 361 7.169 7.342 27 7.799 rVB 0.063 17 7.775 7.838 28 7.979 rVB 0.087 43 7.948 8.035 29 8.113 rBV 0.079 23 8.082 8.16 30 8.444 rBV 0.181 793 8.318 8.499 31 8.577 rBV 0.039 139 8.546 8.585 32 11.102 rBV 0.079 79 11.071 11.15 33 13.525 rBV 0.102 247 13.486 13.588 34 14.084 rVB 0.149 321 14.052 14.202

    5.

    Ion 74.00 (73.70 to 74.70): 01001010.D\data.ms WAL_ZAN_MINT_4

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    Peak # Ret Time Type Width Area Start Time

    End Time

    1 3.158 rBB 0.031 2 3.142 3.173 2 3.221 rVB 0.118 18 3.173 3.291 3 3.362 rBB 0.079 4 3.331 3.409 4 3.504 rBB 0.079 3 3.48 3.559 5 3.567 rBB 0.063 2 3.559 3.622 6 3.763 rBV 0.031 2 3.748 3.779 7 3.842 rBV 0.039 3 3.811 3.85 8 3.999 rBB 0.071 81 3.968 4.039 9 4.086 rBV 0.031 3 4.078 4.11 10 4.204 rBV 0.071 9 4.157 4.228 11 4.353 rBV 0.094 32 4.306 4.401 12 4.448 rVV 0.071 61 4.416 4.487 13 4.511 rVB 0.039 4 4.495 4.534 14 4.597 rBB 0.031 1 4.589 4.621 15 4.668 rBV 0.087 21 4.621 4.707 16 4.833 rBV 0.087 39 4.786 4.873 17 5.329 rBV 0.362 2371589 5.266 5.628 18 5.651 rVV 0.244 4514 5.628 5.872 19 5.895 rVB 0.393 1253 5.872 6.265 20 6.957 rVB 0.087 34 6.941 7.028 21 7.209 rBV 0.165 354 7.162 7.327 22 7.807 rVB 0.071 22 7.775 7.846 23 7.988 rVB 0.079 78 7.948 8.027 24 8.113 rBV 0.055 25 8.082 8.137 25 8.436 rBV 0.197 907 8.31 8.507 26 8.585 rBV 0.063 212 8.538 8.601 27 9.191 rVB 0.197 403 9.167 9.364 28 11.008 rVB 0.071 89 10.985 11.055 29 11.095 rVB 0.149 138 11.071 11.221 30 13.517 rBV 0.118 341 13.478 13.596 31 14.076 rBV 0.118 303 14.044 14.162 32 14.501 rBV 0.087 71 14.477 14.564

    6.

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    Ion 74.00 (73.70 to 74.70): 02801028.D\data.ms 20190412_13

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.158 rBV 0.039 4 3.15 3.189 2 3.213 rVB 0.047 9 3.189 3.236 3 3.37 rBB 0.047 2 3.346 3.394 4 3.496 rBV 0.055 6 3.464 3.519 5 3.653 rVB 0.031 3 3.645 3.677 6 3.732 rVB 0.055 3 3.716 3.771 7 3.842 rVV 0.063 10 3.811 3.873 8 3.881 rVB 0.031 2 3.873 3.905 9 3.991 rBV 0.102 95 3.928 4.031 10 4.039 rBB 0.039 2 4.031 4.07 11 4.086 rVB 0.031 3 4.078 4.109 12 4.117 rBV 0.039 4 4.109 4.149 13 4.196 rBB 0.071 7 4.157 4.227 14 4.259 rBB 0.039 2 4.251 4.29 15 4.345 rBV 0.102 28 4.29 4.393 16 4.44 rVV 0.071 48 4.408 4.479 17 4.503 rBB 0.039 3 4.495 4.534 18 4.55 rVB 0.031 1 4.542 4.574 19 4.605 rBV 0.039 2 4.581 4.621 20 4.66 rBB 0.039 5 4.644 4.684 21 4.817 rBV 0.118 36 4.762 4.88 22 4.959 rBB 0.039 2 4.951 4.99 23 4.998 rBV 0.016 1 4.99 5.006 24 5.03 rVB 0.071 9 5.022 5.093 25 5.101 rBV 0.079 8 5.093 5.171 26 5.195 rBV 0.063 5 5.171 5.234 27 5.313 rBV 0.354 2268331 5.266 5.62 28 5.643 rVV 0.244 3268 5.62 5.864 29 5.887 rVB 0.134 312 5.864 5.997 30 6.957 rVB 0.071 31 6.925 6.996 31 7.201 rBV 0.252 1051 7.146 7.397

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    32 7.783 rVB 0.102 48 7.759 7.862 33 8.318 rBV 0.055 21 8.294 8.349 34 8.428 rBV 0.142 870 8.357 8.499 35 8.774 rBV 0.134 426 8.656 8.79 36 10.143 rVB 0.173 417 10.111 10.284 37 11.008 rBV 0.063 186 10.977 11.039 38 11.095 rVV 0.173 2588 11.047 11.22 39 11.252 rVB 0.149 186 11.228 11.378 40 11.488 rBV 0.063 237 11.448 11.511 41 13.934 rBV 0.181 502 13.871 14.052 42 14.485 rBV 0.11 302 14.445 14.556

    7.

    Ion 74.00 (73.70 to 74.70): 02601026.D\data.ms 20190412_12

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.213 rVB 0.087 19 3.181 3.268 2 3.283 rVB 0.055 4 3.275 3.331 3 3.362 rBV 0.047 3 3.331 3.378 4 3.496 rVB 0.047 5 3.472 3.519 5 3.527 rBB 0.031 1 3.519 3.551 6 3.582 rBB 0.047 3 3.567 3.614 7 3.677 rBV 0.047 3 3.661 3.708 8 3.732 rVB 0.031 3 3.716 3.747 9 3.834 rBB 0.079 15 3.81 3.889 10 3.905 rBB 0.047 2 3.897 3.944 11 3.991 rBB 0.094 91 3.952 4.046 12 4.07 rVB 0.071 6 4.054 4.125 13 4.141 rBV 0.031 2 4.125 4.156 14 4.196 rBV 0.055 7 4.164 4.219 15 4.345 rBV 0.118 41 4.282 4.4

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    16 4.44 rVB 0.079 59 4.408 4.487 17 4.503 rVB 0.047 6 4.487 4.534 18 4.573 rBB 0.039 2 4.55 4.589 19 4.613 rBB 0.024 1 4.597 4.621 20 4.66 rBV 0.063 10 4.621 4.684 21 4.825 rBV 0.157 49 4.739 4.896 22 5.014 rVB 0.087 7 5.006 5.093 23 5.218 rBV 0.047 4 5.195 5.242 24 5.321 rBV 0.362 2941436 5.258 5.62 25 5.643 rVV 0.236 4423 5.62 5.856 26 5.887 rVB 0.126 389 5.863 5.989 27 6.957 rVB 0.094 41 6.933 7.028 28 7.201 rBV 0.267 1476 7.161 7.429 29 7.783 rVB 0.11 50 7.759 7.869 30 8.318 rVB 0.047 12 8.302 8.349 31 8.428 rBV 0.134 829 8.357 8.491 32 8.774 rBV 0.126 331 8.656 8.782 33 11.008 rVB 0.063 81 10.984 11.047 34 11.094 rVV 0.142 844 11.063 11.205

    8.

    Ion 74.00 (73.70 to 74.70): 01201012.D\data.ms RANITIDINE_5

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.213 rVB 0.102 18 3.189 3.291 2 3.323 rBB 0.055 3 3.299 3.354 3 3.409 rVB 0.047 3 3.401 3.449 4 3.504 rBV 0.055 5 3.472 3.527 5 3.59 rVB 0.031 3 3.574 3.606 6 3.614 rBV 0.024 2 3.606 3.63

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    7 3.748 rVB 0.071 6 3.74 3.81 8 3.834 rBV 0.094 13 3.81 3.905 9 3.921 rBB 0.047 4 3.913 3.96 10 3.999 rBB 0.094 83 3.96 4.054 11 4.062 rBV 0.039 3 4.054 4.094 12 4.149 rBV 0.024 2 4.141 4.164 13 4.204 rBB 0.031 2 4.188 4.219 14 4.235 rBV 0.024 2 4.219 4.243 15 4.267 rBB 0.031 1 4.251 4.282 16 4.377 rBV 0.094 21 4.298 4.393 17 4.448 rVB 0.071 44 4.416 4.487 18 4.605 rBB 0.031 2 4.589 4.621 19 4.668 rBV 0.055 11 4.644 4.699 20 4.825 rBV 0.087 35 4.778 4.865 21 5.329 rBV 0.354 2231924 5.274 5.628 22 5.651 rVB 0.236 3723 5.628 5.864 23 7.216 rBB 0.149 274 7.169 7.319 24 8.003 rVB 0.071 50 7.987 8.058 25 8.113 rBV 0.063 23 8.097 8.16 26 8.389 rBV 0.212 730 8.286 8.499 27 8.562 rBV 0.039 149 8.538 8.577 28 9.191 rVB 0.252 530 9.159 9.411 29 11.008 rVB 0.071 90 10.984 11.055 30 11.094 rVB 0.071 99 11.063 11.134 31 12.613 rVB 0.063 59 12.597 12.66 32 13.517 rBV 0.189 588 13.486 13.675 33 14.076 rBV 0.118 290 14.044 14.162 34 14.5 rBV 0.071 67 14.477 14.548

    9.

    Ion 74.00 (73.70 to 74.70): 02401024.D\data.ms 20190412_11

    Peak # Ret Time Type Width Area Start

    Time End Time

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    1 3.213 rVB 0.134 18 3.181 3.315 2 3.346 rBV 0.039 4 3.339 3.378 3 3.401 rBV 0.039 3 3.394 3.433 4 3.496 rVB 0.079 8 3.464 3.543 5 3.59 rBB 0.063 4 3.543 3.606 6 3.614 rBB 0.047 1 3.606 3.653 7 3.779 rBB 0.047 2 3.771 3.818 8 3.842 rBB 0.087 8 3.818 3.905 9 3.991 rBB 0.134 92 3.936 4.07 10 4.094 rBB 0.063 2 4.086 4.149 11 4.204 rBV 0.055 7 4.172 4.227 12 4.345 rBV 0.11 34 4.29 4.4 13 4.44 rVB 0.087 42 4.4 4.487 14 4.511 rBV 0.047 6 4.487 4.534 15 4.621 rBV 0.047 3 4.581 4.629 16 4.66 rBB 0.055 5 4.644 4.699 17 4.825 rBV 0.126 37 4.739 4.865 18 4.943 rBB 0.039 2 4.935 4.975 19 5.179 rVB 0.024 2 5.171 5.195 20 5.203 rBV 0.039 3 5.195 5.234 21 5.313 rBV 0.378 2524866 5.242 5.62 22 5.643 rVV 0.228 3778 5.62 5.848 23 5.887 rVB 0.205 574 5.864 6.068 24 6.957 rVB 0.087 32 6.925 7.012 25 7.201 rBV 0.244 1171 7.146 7.39 26 7.783 rVB 0.142 59 7.751 7.893 27 8.326 rBV 0.055 24 8.302 8.357 28 8.428 rBV 0.11 657 8.357 8.467 29 8.805 rBV 0.173 571 8.656 8.829 30 11.095 rVB 0.157 1968 11.063 11.22 31 11.488 rBV 0.047 34 11.464 11.511 32 11.818 rVB 0.055 38 11.802 11.858 33 13.62 rBV 0.134 245 13.564 13.698 34 14.493 rBV 0.094 154 14.445 14.54

    10.

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    Ion 74.00 (73.70 to 74.70): 01601016.D\data.ms RANITIDINE_7

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.126 rVB 0.031 3 3.118 3.15 2 3.158 rBV 0.031 3 3.15 3.181 3 3.417 rBB 0.039 2 3.409 3.449 4 3.472 rBB 0.039 2 3.449 3.488 5 3.504 rBB 0.063 4 3.488 3.551 6 3.59 rBB 0.055 3 3.575 3.63 7 3.708 rVB 0.031 2 3.7 3.732 8 3.755 rBB 0.055 4 3.732 3.787 9 3.842 rBV 0.102 12 3.787 3.889 10 3.999 rBB 0.094 88 3.952 4.046 11 4.102 rBB 0.031 2 4.086 4.117 12 4.125 rBB 0.031 1 4.117 4.149 13 4.204 rBB 0.063 6 4.172 4.235 14 4.259 rBV 0.039 2 4.235 4.275 15 4.353 rBB 0.205 37 4.306 4.511 16 4.518 rBB 0.047 2 4.511 4.558 17 4.589 rBB 0.047 3 4.558 4.605 18 4.621 rBB 0.031 2 4.605 4.636 19 4.668 rBV 0.071 13 4.636 4.707 20 4.747 rBV 0.055 4 4.715 4.77 21 5.006 rBB 0.055 3 4.983 5.038 22 5.045 rBV 0.024 2 5.038 5.061 23 5.242 rBB 0.047 3 5.219 5.266 24 5.329 rBV 0.362 2656658 5.266 5.628 25 5.651 rVB 0.244 4006 5.628 5.871 26 7.209 rBV 0.205 443 7.177 7.382 27 7.799 rVB 0.079 26 7.775 7.854 28 7.987 rVB 0.094 69 7.956 8.05 29 8.129 rBV 0.055 23 8.113 8.168 30 8.436 rBV 0.228 1048 8.286 8.514 31 8.593 rBV 0.055 220 8.554 8.609

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    32 11.008 rBV 0.063 80 10.984 11.047 33 11.095 rVB 0.071 98 11.071 11.142 34 14.084 rBV 0.118 559 14.044 14.162 35 14.501 rBV 0.087 88 14.477 14.563

    GCMS Date ran

    Sequence name File Name

    Ranitidine Tablet Studies Lot# 77024060A

    NDMA per tablet above control (ng)

    11 EX_GCMS

    20190410

    20190410_RANITIDINE_POWDER_LOWTEEMP_RUN_1

    06601002

    Tablet w/out Solvent

    Not Detected

    12 EX_GCMS

    20190331

    20190331_RANITIDINE_RUN_1 00201002

    Tablet Not Detected

    13 SS_GCMS

    20190509

    20190509_RANITIDINE_SIG_SIG_TEST_RUN_1

    00601007

    Simulated Gastric Conditions - Fasting

    Not Detected

    14 SS_GCMS

    20190509

    20190509_RANITIDINE_SIG_SIG_TEST_RUN_1

    00501006

    Simulated Intestinal Conditions - Fasting

    Not Detected

    15 SS_GCMS

    20190423

    20190423_H2O_CALI_NNaO2_TEST_RUN_1 01201013

    SGF with 10 mM Sodium Nitrite

    Not Detected

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    16 SS_GCMS

    20190423

    20190423_H2O_CALI_NNaO2_TEST_RUN_1 01301014

    SGF with 25 mM Sodium Nitrite

    (A=21) 236

    17 SS_GCMS

    20190422

    20190422_RANITIDINE_NNaO2_NNaO3_STUDY_RUN_1

    00801014

    SGF with 50 mM Sodium Nitrite

    (A=244) 3045

    11.

    Ion 74.00 (73.70 to 74.70): 06601002.D\data.ms RANITIDINE_POWDER

    Peak # Ret Time Type Width Area Start Time End Time 1 11.213 rBB 0.063 105 11.182 11.245 2 12.003 rBB 0.063 97 11.972 12.035 3 12.778 rBB 0.063 138 12.746 12.809 4 13.584 rBB 0.095 272 13.552 13.647 5 14.073 rBB 0.079 237 14.026 14.105 6 14.279 rBB 0.063 116 14.247 14.311 7 14.342 rBB 0.047 100 14.326 14.374 8 14.611 rBB 0.063 189 14.579 14.642 9 14.721 rBB 0.063 122 14.69 14.753

    12.

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    Ion 74.00 (73.70 to 74.70): 00201002.D\data.ms Ranitidine_Incubated

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.331 rVB 0.039 2 3.323 3.362 2 3.37 rVB 0.047 4 3.362 3.409 3 3.417 rBV 0.039 3 3.409 3.449 4 3.543 rVB 0.047 3 3.527 3.575 5 3.637 rBB 0.031 1 3.63 3.661 6 3.858 rBB 0.094 7 3.826 3.921 7 4.102 rVB 0.024 1 4.094 4.117 8 4.133 rBV 0.031 2 4.117 4.149 9 4.235 rBV 0.024 2 4.227 4.251 10 4.322 rBB 0.039 1 4.306 4.345 11 4.487 rVB 0.031 1 4.471 4.503 12 4.621 rBB 0.039 2 4.613 4.652 13 4.676 rBV 0.047 4 4.652 4.699 14 4.88 rVB 0.039 2 4.865 4.904 15 5.148 rBV 0.055 4 5.108 5.163 16 5.203 rVB 0.031 2 5.187 5.219 17 5.242 rBV 0.039 3 5.219 5.258 18 5.439 rBB 0.079 3 5.423 5.502 19 5.659 rBV 0.189 298 5.612 5.801 20 6.013 rBB 0.031 1 5.997 6.029 21 6.249 rBB 0.031 1 6.241 6.273 22 6.296 rBB 0.047 2 6.273 6.32 23 6.469 rBB 0.039 2 6.461 6.501 24 6.65 rBV 0.024 2 6.642 6.666 25 6.76 rVB 0.031 2 6.752 6.784 26 6.886 rBB 0.118 7 6.784 6.902 27 6.957 rBV 0.079 10 6.91 6.988 28 7.059 rBB 0.055 3 7.043 7.099 29 7.106 rBB 0.047 2 7.099 7.146 30 7.154 rBB 0.063 3 7.146 7.209 31 7.311 rBB 0.126 8 7.209 7.334

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    32 7.342 rBV 0.024 2 7.334 7.358 33 7.57 rVB 0.047 4 7.563 7.61 34 7.633 rBV 0.047 4 7.61 7.657 35 7.704 rBB 0.039 1 7.696 7.736 36 7.751 rVB 0.039 3 7.744 7.783 37 7.799 rBB 0.039 3 7.783 7.822 38 7.838 rBV 0.031 3 7.822 7.854 39 7.877 rVB 0.031 2 7.869 7.901 40 7.909 rBB 0.031 1 7.901 7.932 41 7.987 rBB 0.039 2 7.98 8.019 42 8.294 rBB 0.031 1 8.278 8.31 43 8.326 rBV 0.031 3 8.31 8.341 44 8.42 rBV 0.142 181 8.357 8.499 45 8.876 rBB 0.039 1 8.868 8.908 46 8.994 rBB 0.039 1 8.986 9.026 47 9.136 rBV 0.024 2 9.12 9.144 48 9.214 rVV 0.126 37 9.152 9.277 49 10.654 rBV 0.039 6 10.63 10.67 50 10.945 rVB 0.087 37 10.914 11 51 11.079 rBV 0.047 21 11.063 11.11 52 11.236 rVB 0.267 493 11.126 11.393 53 12.361 rBV 0.087 40 12.345 12.432 54 13.627 rVB 0.134 97 13.588 13.722

    13.

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    Ion 74.00 (73.70 to 74.70): 00601007.D\data.ms 8-SGF+RANITIDINE 100ML

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.197 rBV 0.039 3 3.174 3.213 2 3.229 rVV 0.031 3 3.221 3.252 3 3.268 rVB 0.039 3 3.26 3.299 4 3.315 rVB 0.031 3 3.307 3.339 5 3.354 rBB 0.024 1 3.347 3.37 6 3.417 rBB 0.039 2 3.394 3.433 7 3.457 rBB 0.055 3 3.433 3.488 8 3.496 rBB 0.031 2 3.488 3.52 9 3.543 rBB 0.031 2 3.52 3.551 10 3.645 rVB 0.102 6 3.638 3.74 11 3.748 rVB 0.055 4 3.74 3.795 12 3.803 rBV 0.031 3 3.795 3.826 13 3.874 rBB 0.031 1 3.866 3.897 14 3.944 rBB 0.055 3 3.905 3.96 15 3.968 rBB 0.063 2 3.96 4.023 16 4.047 rBB 0.047 1 4.031 4.078 17 4.094 rBB 0.024 1 4.086 4.11 18 4.188 rBB 0.039 1 4.165 4.204 19 4.267 rBB 0.087 6 4.235 4.322 20 4.361 rVB 0.024 2 4.353 4.377 21 4.385 rBV 0.047 4 4.377 4.424 22 4.44 rBB 0.031 1 4.432 4.464 23 4.495 rBB 0.055 2 4.479 4.534 24 4.542 rBB 0.031 1 4.534 4.566 25 4.582 rBB 0.031 1 4.574 4.605 26 4.621 rBB 0.024 1 4.613 4.637 27 4.692 rVB 0.079 15 4.652 4.731 28 4.802 rBV 0.094 9 4.731 4.825

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    29 4.841 rBB 0.031 1 4.833 4.865 30 4.936 rBB 0.047 2 4.92 4.967 31 5.006 rBB 0.047 2 4.991 5.038 32 5.046 rBB 0.055 2 5.038 5.093 33 5.195 rBB 0.047 2 5.179 5.227 34 5.242 rVB 0.047 5 5.227 5.274 35 5.313 rBB 0.055 3 5.274 5.329 36 5.345 rBV 0.063 6 5.329 5.392 37 5.4 rBB 0.039 2 5.392 5.431 38 5.455 rBB 0.055 2 5.447 5.502 39 5.518 rBB 0.031 1 5.51 5.541 40 5.549 rBB 0.031 1 5.541 5.573 41 5.588 rBV 0.031 2 5.573 5.604 42 5.628 rBV 0.024 2 5.62 5.644 43 5.714 rBB 0.047 3 5.683 5.73 44 5.793 rBV 0.047 3 5.777 5.824 45 5.848 rVV 0.047 5 5.84 5.887 46 5.927 rVV 0.031 3 5.919 5.95 47 5.966 rVB 0.031 2 5.958 5.99 48 6.021 rBB 0.055 4 5.99 6.045 49 6.068 rBB 0.055 4 6.045 6.1 50 6.108 rBB 0.031 1 6.1 6.131 51 6.147 rBV 0.055 4 6.131 6.186 52 6.351 rVB 0.063 4 6.344 6.407 53 6.422 rBB 0.024 1 6.407 6.43 54 6.564 rBV 0.039 3 6.556 6.595 55 6.619 rVV 0.031 3 6.611 6.643 56 6.69 rVV 0.071 8 6.65 6.721 57 6.737 rVB 0.024 1 6.729 6.753 58 6.776 rBV 0.055 5 6.753 6.808 59 6.863 rVB 0.134 13 6.839 6.973 60 6.989 rBB 0.055 3 6.973 7.028 61 7.052 rBB 0.039 1 7.044 7.083 62 7.107 rBB 0.031 1 7.099 7.13 63 7.17 rBB 0.024 1 7.154 7.177 64 7.209 rBB 0.055 8 7.185 7.24 65 7.264 rVB 0.031 3 7.248 7.28 66 7.295 rBV 0.024 2 7.28 7.303 67 7.358 rBB 0.031 1 7.35 7.382 68 7.39 rBB 0.039 2 7.382 7.421 69 7.445 rBV 0.024 2 7.437 7.461

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    70 7.476 rVB 0.024 2 7.468 7.492 71 7.5 rBV 0.031 3 7.492 7.524 72 7.539 rBB 0.055 1 7.531 7.586 73 7.61 rVB 0.087 9 7.594 7.681 74 7.689 rBV 0.094 14 7.681 7.775 75 7.807 rBV 0.047 3 7.775 7.822 76 7.878 rBB 0.047 2 7.87 7.917 77 8.003 rBV 0.024 3 7.995 8.019 78 8.035 rVB 0.047 4 8.027 8.074 79 8.082 rBV 0.039 4 8.074 8.113 80 8.161 rBB 0.063 4 8.137 8.2 81 8.247 rBV 0.024 3 8.231 8.255 82 8.287 rVB 0.087 10 8.263 8.349 83 8.373 rBB 0.039 3 8.357 8.397 84 8.405 rBB 0.031 1 8.397 8.428 85 8.46 rBV 0.055 3 8.428 8.483 86 8.507 rVB 0.039 3 8.499 8.538 87 8.554 rVB 0.039 4 8.546 8.585 88 8.593 rBV 0.031 3 8.585 8.617 89 8.625 rBB 0.055 3 8.617 8.672 90 8.727 rBV 0.197 907 8.68 8.877 91 9.002 rVB 0.055 8 8.995 9.05 92 9.073 rBV 0.024 2 9.065 9.089 93 9.23 rBV 0.024 2 9.223 9.246 94 9.561 rBB 0.039 3 9.545 9.584 95 9.592 rBV 0.031 3 9.584 9.616 96 10.056 rBB 0.031 1 10.049 10.08 97 10.277 rBV 0.031 3 10.253 10.285 98 10.481 rBB 0.031 2 10.465 10.497 99 10.521 rBV 0.031 3 10.505 10.536 100 10.985 rBV 0.024 3 10.969 10.993

    14.

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    Ion 74.00 (73.70 to 74.70): 00501006.D\data.ms 7-SIF+RANITIDINE 100ML

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.355 rBB 0.039 2 3.347 3.386 2 3.394 rBB 0.047 2 3.386 3.433 3 3.441 rBB 0.047 2 3.433 3.48 4 3.496 rBB 0.024 1 3.488 3.512 5 3.528 rBB 0.031 1 3.52 3.551 6 3.622 rVB 0.071 5 3.606 3.677 7 3.709 rBV 0.055 4 3.677 3.732 8 3.811 rBB 0.031 1 3.803 3.834 9 3.85 rVB 0.039 3 3.842 3.882 10 3.913 rBB 0.039 2 3.897 3.937 11 3.945 rBB 0.039 2 3.937 3.976 12 4.015 rBB 0.063 4 3.976 4.039 13 4.047 rBB 0.047 2 4.039 4.086 14 4.102 rBB 0.031 1 4.094 4.125 15 4.251 rBV 0.087 11 4.212 4.299 16 4.33 rVV 0.039 5 4.306 4.346 17 4.385 rVV 0.039 4 4.377 4.417 18 4.448 rVB 0.063 6 4.432 4.495 19 4.527 rBB 0.039 1 4.511 4.55

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    20 4.558 rBB 0.031 2 4.55 4.582 21 4.605 rBB 0.063 2 4.597 4.66 22 4.692 rBB 0.071 10 4.676 4.747 23 4.771 rBB 0.039 2 4.747 4.786 24 4.794 rBB 0.031 1 4.786 4.818 25 4.888 rBB 0.047 3 4.849 4.896 26 4.92 rBB 0.031 2 4.896 4.928 27 4.967 rBB 0.031 1 4.959 4.991 28 5.022 rBB 0.039 1 5.014 5.054 29 5.101 rBB 0.024 1 5.085 5.109 30 5.124 rBB 0.039 2 5.109 5.148 31 5.156 rBV 0.024 2 5.148 5.172 32 5.266 rVB 0.055 5 5.242 5.298 33 5.321 rBV 0.031 2 5.305 5.337 34 5.392 rBB 0.079 5 5.384 5.463 35 5.494 rBV 0.024 2 5.486 5.51 36 5.541 rBB 0.047 4 5.534 5.581 37 5.596 rBV 0.031 3 5.581 5.612 38 5.628 rBB 0.047 2 5.62 5.667 39 5.754 rBV 0.039 3 5.73 5.769 40 5.777 rVB 0.063 5 5.769 5.832 41 5.848 rBV 0.071 7 5.832 5.903 42 5.935 rBB 0.039 1 5.927 5.966 43 6.037 rBV 0.087 8 6.005 6.092 44 6.171 rBB 0.047 1 6.163 6.21 45 6.234 rVB 0.047 4 6.218 6.265 46 6.297 rBV 0.071 6 6.273 6.344 47 6.375 rBB 0.031 1 6.359 6.391 48 6.399 rBB 0.039 1 6.391 6.43 49 6.454 rBB 0.039 1 6.446 6.485 50 6.493 rBB 0.047 3 6.485 6.533 51 6.611 rBB 0.024 1 6.603 6.627 52 6.674 rBB 0.094 6 6.643 6.737 53 6.776 rBV 0.039 2 6.753 6.792 54 6.816 rBB 0.031 1 6.808 6.839 55 6.863 rBB 0.071 4 6.855 6.926 56 6.981 rBV 0.063 6 6.957 7.02 57 7.075 rBB 0.055 4 7.067 7.122 58 7.162 rBV 0.024 2 7.154 7.178 59 7.209 rVB 0.063 9 7.193 7.256 60 7.288 rBB 0.031 2 7.272 7.303

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    61 7.311 rBB 0.079 4 7.303 7.382 62 7.39 rVB 0.039 4 7.382 7.421 63 7.437 rBV 0.031 3 7.421 7.453 64 7.492 rBB 0.087 6 7.453 7.539 65 7.579 rBV 0.063 5 7.539 7.602 66 7.705 rBV 0.102 13 7.65 7.752 67 7.799 rBV 0.055 5 7.791 7.846 68 7.996 rBB 0.031 2 7.988 8.019 69 8.027 rBB 0.016 1 8.019 8.035 70 8.161 rBB 0.039 2 8.129 8.169 71 8.184 rBV 0.031 3 8.169 8.2 72 8.287 rBV 0.055 9 8.263 8.318 73 8.617 rBB 0.031 1 8.609 8.641 74 8.727 rBV 0.126 826 8.688 8.814 75 9.191 rBB 0.047 2 9.168 9.215 76 9.238 rBB 0.031 2 9.231 9.262 77 10.34 rBV 0.039 4 10.324 10.363 78 10.544 rBB 0.031 2 10.529 10.56 79 10.694 rBB 0.024 1 10.686 10.709 80 10.772 rBV 0.039 4 10.765 10.804

    15.

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    Ion 74.00 (73.70 to 74.70): 01201013.D\data.ms SGF+10mM NNaO2 0.1L RANITIDINE

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.284 rBV 0.055 5 3.276 3.331 2 3.37 rBB 0.055 2 3.362 3.418 3 3.528 rVB 0.031 2 3.52 3.551 4 3.591 rBB 0.071 5 3.551 3.622 5 3.638 rBB 0.039 2 3.622 3.661 6 3.701 rBB 0.024 1 3.685 3.709 7 3.724 rBV 0.031 2 3.709 3.74 8 3.787 rBB 0.063 5 3.771 3.834 9 3.842 rBB 0.039 3 3.834 3.874 10 3.889 rBB 0.039 2 3.874 3.913 11 3.96 rVB 0.039 3 3.945 3.984 12 4 rBB 0.039 3 3.984 4.023 13 4.031 rBB 0.055 4 4.023 4.078 14 4.11 rBB 0.055 3 4.078 4.133 15 4.141 rBB 0.039 2 4.133 4.173 16 4.188 rBV 0.039 3 4.173 4.212 17 4.259 rBB 0.071 4 4.22 4.291 18 4.377 rBB 0.024 1 4.361 4.385 19 4.448 rBB 0.047 4 4.44 4.487 20 4.495 rBB 0.016 1 4.487 4.503 21 4.566 rBB 0.071 4 4.527 4.597 22 4.605 rBV 0.024 1 4.597 4.621 23 4.652 rBV 0.024 2 4.637 4.66 24 4.692 rBV 0.063 13 4.676 4.739 25 4.763 rVB 0.031 2 4.747 4.778 26 4.81 rBB 0.031 1 4.802 4.833 27 4.944 rBB 0.047 4 4.936 4.983

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    28 4.999 rBB 0.024 1 4.991 5.014 29 5.022 rBB 0.031 1 5.014 5.046 30 5.054 rBB 0.047 2 5.046 5.093 31 5.101 rBV 0.055 5 5.093 5.148 32 5.242 rBV 0.055 4 5.203 5.258 33 5.321 rVB 0.031 2 5.313 5.345 34 5.368 rBV 0.039 3 5.345 5.384 35 5.463 rBB 0.039 1 5.455 5.494 36 5.518 rBV 0.031 3 5.51 5.541 37 5.581 rBB 0.126 8 5.541 5.667 38 5.691 rVB 0.055 4 5.675 5.73 39 5.809 rBB 0.071 3 5.762 5.832 40 5.872 rVB 0.024 1 5.864 5.887 41 5.895 rBB 0.031 1 5.887 5.919 42 5.95 rBV 0.039 4 5.927 5.966 43 5.99 rBB 0.047 1 5.974 6.021 44 6.084 rBB 0.031 1 6.068 6.1 45 6.139 rVB 0.047 4 6.131 6.179 46 6.194 rBB 0.039 3 6.186 6.226 47 6.281 rBV 0.063 4 6.226 6.289 48 6.328 rBV 0.024 2 6.32 6.344 49 6.352 rBB 0.047 1 6.344 6.391 50 6.407 rBB 0.031 1 6.399 6.43 51 6.438 rVB 0.039 3 6.43 6.47 52 6.493 rBB 0.047 4 6.47 6.517 53 6.533 rBV 0.055 5 6.517 6.572 54 6.588 rBB 0.024 1 6.58 6.603 55 6.611 rBB 0.031 1 6.603 6.635 56 6.666 rBB 0.039 2 6.658 6.698 57 6.808 rBB 0.024 1 6.8 6.824 58 6.839 rBV 0.024 2 6.824 6.847 59 6.871 rVB 0.024 2 6.855 6.879 60 6.949 rBB 0.031 3 6.942 6.973 61 7.004 rBV 0.055 5 6.973 7.028 62 7.067 rBB 0.031 2 7.044 7.075 63 7.091 rVB 0.031 3 7.083 7.115 64 7.146 rBV 0.047 6 7.115 7.162 65 7.209 rVB 0.063 8 7.178 7.24 66 7.248 rBB 0.031 1 7.24 7.272 67 7.303 rBV 0.039 3 7.296 7.335 68 7.358 rVV 0.055 8 7.335 7.39

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    69 7.429 rVV 0.039 4 7.406 7.445 70 7.461 rVB 0.047 5 7.445 7.492 71 7.5 rBV 0.039 4 7.492 7.532 72 7.579 rVV 0.055 7 7.547 7.602 73 7.61 rVB 0.055 7 7.602 7.657 74 7.878 rBB 0.024 1 7.87 7.893 75 8.074 rBB 0.031 2 8.059 8.09 76 8.137 rBV 0.047 3 8.098 8.145 77 8.161 rVB 0.047 3 8.153 8.2 78 8.216 rBB 0.031 1 8.208 8.239 79 8.247 rBV 0.024 2 8.239 8.263 80 8.295 rVB 0.063 6 8.263 8.326 81 8.42 rBV 0.079 8 8.365 8.444 82 8.507 rVB 0.031 2 8.499 8.531 83 8.546 rBB 0.039 3 8.531 8.57 84 8.586 rBV 0.024 2 8.57 8.593 85 8.727 rBV 0.189 892 8.68 8.869 86 9.309 rVB 0.079 8 9.294 9.372 87 9.537 rBV 0.031 2 9.522 9.553 88 9.703 rBV 0.063 8 9.695 9.758 89 9.852 rBV 0.039 4 9.836 9.876 90 9.899 rVB 0.047 4 9.891 9.939 91 11.205 rBB 0.055 4 11.181 11.237

    16.

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    Ion 74.00 (73.70 to 74.70): 01301014.D\data.ms SGF+25mM NNaO2 0.1L RANITIDINE

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.354 rVB 0.024 2 3.347 3.37 2 3.386 rBV 0.039 3 3.378 3.417 3 3.449 rVB 0.024 2 3.441 3.465 4 3.48 rBV 0.031 2 3.465 3.496 5 3.551 rBB 0.047 3 3.535 3.583 6 3.622 rBB 0.047 3 3.59 3.638 7 3.646 rBB 0.039 2 3.638 3.677 8 3.732 rBV 0.063 8 3.708 3.771 9 3.779 rBB 0.071 5 3.771 3.842 10 3.882 rBV 0.039 3 3.85 3.889 11 3.905 rVB 0.047 3 3.897 3.944 12 3.96 rBV 0.039 3 3.944 3.984 13 4.047 rBB 0.031 2 4.039 4.07 14 4.078 rBB 0.047 3 4.07 4.117 15 4.125 rBV 0.024 2 4.117 4.141 16 4.165 rVV 0.047 4 4.157 4.204 17 4.267 rBB 0.063 7 4.228 4.291 18 4.298 rBB 0.039 3 4.291 4.33 19 4.338 rBB 0.031 2 4.33 4.361 20 4.369 rBB 0.031 1 4.361 4.393 21 4.409 rBB 0.024 1 4.401 4.424 22 4.432 rBB 0.016 1 4.424 4.44 23 4.448 rBB 0.039 3 4.44 4.479 24 4.495 rBB 0.031 2 4.479 4.511 25 4.519 rBB 0.031 1 4.511 4.542 26 4.55 rBV 0.024 2 4.542 4.566 27 4.637 rBB 0.039 2 4.621 4.66 28 4.7 rBB 0.063 11 4.668 4.731

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    29 4.739 rBB 0.071 2 4.731 4.802 30 4.825 rVB 0.063 4 4.818 4.881 31 4.912 rBB 0.031 2 4.896 4.928 32 4.951 rBB 0.047 2 4.928 4.975 33 5.069 rBB 0.039 2 5.038 5.077 34 5.101 rBB 0.039 2 5.077 5.116 35 5.124 rBB 0.024 1 5.116 5.14 36 5.148 rBB 0.039 2 5.14 5.179 37 5.187 rBB 0.016 1 5.179 5.195 38 5.234 rVB 0.063 3 5.211 5.274 39 5.455 rBB 0.039 2 5.431 5.47 40 5.518 rBV 0.024 2 5.502 5.526 41 5.541 rVB 0.031 2 5.533 5.565 42 5.588 rBV 0.079 21 5.565 5.644 43 5.651 rVB 0.031 3 5.644 5.675 44 5.683 rBV 0.024 2 5.675 5.699 45 5.706 rBB 0.063 2 5.699 5.762 46 5.785 rBB 0.031 1 5.777 5.809 47 5.856 rVB 0.063 5 5.848 5.911 48 5.919 rBB 0.039 1 5.911 5.95 49 5.958 rBV 0.039 3 5.95 5.99 50 5.998 rVV 0.047 4 5.99 6.037 51 6.06 rVB 0.024 1 6.053 6.076 52 6.084 rBB 0.024 1 6.076 6.1 53 6.123 rBB 0.031 2 6.108 6.139 54 6.194 rBB 0.039 2 6.178 6.218 55 6.273 rBB 0.047 3 6.233 6.281 56 6.296 rBB 0.031 2 6.281 6.312 57 6.383 rVB 0.055 3 6.375 6.43 58 6.438 rBV 0.024 2 6.43 6.454 59 6.477 rVV 0.031 3 6.469 6.501 60 6.54 rVB 0.024 2 6.532 6.556 61 6.619 rBB 0.024 1 6.611 6.635 62 6.682 rBB 0.039 1 6.666 6.705 63 6.713 rBB 0.031 1 6.705 6.737 64 6.776 rBB 0.047 2 6.761 6.808 65 6.989 rBB 0.087 7 6.949 7.036 66 7.052 rBV 0.024 2 7.044 7.067 67 7.17 rBV 0.047 3 7.138 7.185 68 7.217 rBB 0.055 4 7.193 7.248 69 7.343 rBV 0.047 4 7.327 7.374

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    70 7.398 rBB 0.047 2 7.382 7.429 71 7.524 rBB 0.031 1 7.516 7.547 72 7.571 rBB 0.039 2 7.555 7.594 73 7.61 rBB 0.031 2 7.602 7.634 74 7.642 rBV 0.024 1 7.634 7.657 75 7.697 rBB 0.063 6 7.673 7.736 76 7.799 rBB 0.024 1 7.783 7.807 77 7.933 rBB 0.047 2 7.901 7.948 78 8.019 rVB 0.031 3 8.011 8.043 79 8.074 rBB 0.079 7 8.043 8.121 80 8.153 rBB 0.055 5 8.121 8.176 81 8.184 rBV 0.024 2 8.176 8.2 82 8.208 rBB 0.031 1 8.2 8.232 83 8.294 rBB 0.094 10 8.239 8.334 84 8.357 rBV 0.039 3 8.342 8.381 85 8.483 rBB 0.055 4 8.46 8.515 86 8.727 rBV 0.142 907 8.688 8.829 87 9.317 rBB 0.047 3 9.301 9.348 88 9.419 rBB 0.039 4 9.411 9.451 89 9.522 rBB 0.063 5 9.498 9.561 90 9.954 rBB 0.055 3 9.931 9.986 91 10.049 rBB 0.039 4 10.033 10.072 92 10.214 rBB 0.047 3 10.198 10.245 93 10.403 rBB 0.055 3 10.387 10.442 94 10.639 rBB 0.039 4 10.631 10.67

    17.

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    Ion 74.00 (73.70 to 74.70): 00801014.D\data.ms 2 SGF+50mM NNaO2 0.1L

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.134 rVB 0.071 7 3.119 3.189 2 3.37 rBB 0.047 2 3.362 3.41 3 3.48 rBV 0.039 3 3.465 3.504 4 3.528 rBB 0.031 1 3.52 3.551 5 3.646 rVB 0.071 6 3.63 3.701 6 3.709 rBV 0.024 2 3.701 3.724 7 3.756 rVB 0.024 1 3.748 3.771 8 3.795 rBB 0.047 4 3.779 3.827 9 3.952 rBV 0.031 4 3.937 3.968 10 3.992 rVV 0.047 5 3.984 4.031 11 4.047 rVV 0.031 3 4.039 4.07 12 4.094 rBV 0.024 2 4.086 4.11 13 4.149 rVB 0.031 2 4.141 4.173 14 4.18 rBB 0.063 3 4.173 4.236 15 4.259 rBB 0.063 6 4.243 4.306 16 4.322 rBB 0.031 1 4.314 4.346 17 4.377 rBB 0.031 1 4.354 4.385 18 4.44 rVB 0.047 4 4.432 4.479 19 4.495 rBV 0.031 3 4.479 4.511 20 4.527 rVB 0.039 3 4.519 4.558 21 4.582 rBV 0.047 4 4.558 4.605 22 4.645 rVV 0.031 3 4.629 4.66 23 4.692 rVB 0.087 14 4.668 4.755 24 4.77 rBB 0.039 2 4.763 4.802 25 4.81 rBB 0.063 3 4.802 4.865 26 4.888 rVB 0.047 4 4.865 4.912 27 4.92 rBV 0.039 4 4.912 4.951 28 4.991 rBV 0.016 2 4.983 4.999 29 5.03 rVB 0.031 1 5.014 5.046 30 5.109 rBB 0.055 3 5.101 5.156 31 5.195 rBB 0.047 3 5.187 5.235 32 5.25 rBB 0.047 2 5.242 5.29 33 5.313 rBB 0.039 3 5.297 5.337 34 5.368 rBB 0.016 1 5.36 5.376 35 5.384 rBB 0.031 2 5.376 5.408 36 5.431 rBV 0.039 3 5.408 5.447 37 5.486 rBB 0.024 1 5.478 5.502

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    38 5.518 rBB 0.016 1 5.51 5.526 39 5.589 rBV 0.102 244 5.557 5.659 40 5.825 rBB 0.024 1 5.817 5.84 41 5.903 rBV 0.039 4 5.895 5.935 42 5.95 rBB 0.031 1 5.942 5.974 43 6.045 rBB 0.055 3 6.029 6.084 44 6.1 rBB 0.024 1 6.092 6.116 45 6.139 rBB 0.024 1 6.131 6.155 46 6.163 rBB 0.047 2 6.155 6.202 47 6.21 rBV 0.024 2 6.202 6.226 48 6.281 rBV 0.031 3 6.265 6.296 49 6.328 rBV 0.039 2 6.304 6.344 50 6.391 rBV 0.047 4 6.375 6.422 51 6.462 rBB 0.031 2 6.438 6.47 52 6.485 rBV 0.024 2 6.47 6.493 53 6.509 rBB 0.031 1 6.501 6.532 54 6.588 rBV 0.047 4 6.564 6.611 55 6.682 rVB 0.031 2 6.674 6.706 56 6.753 rBB 0.071 7 6.706 6.776 57 6.8 rVB 0.047 4 6.776 6.824 58 6.863 rBV 0.079 14 6.824 6.902 59 6.981 rBV 0.055 7 6.957 7.012 60 7.02 rVB 0.047 5 7.012 7.06 61 7.067 rBB 0.031 3 7.06 7.091 62 7.122 rBV 0.039 3 7.099 7.138 63 7.154 rVB 0.024 1 7.146 7.17 64 7.209 rBB 0.071 8 7.17 7.24 65 7.248 rBV 0.047 6 7.24 7.288 66 7.303 rBB 0.024 1 7.295 7.319 67 7.366 rBV 0.024 2 7.358 7.382 68 7.445 rBV 0.031 3 7.421 7.453 69 7.476 rBV 0.039 4 7.453 7.492 70 7.5 rVB 0.055 6 7.492 7.547 71 7.555 rBV 0.094 10 7.547 7.642 72 7.657 rBB 0.031 1 7.649 7.681 73 7.697 rBB 0.024 2 7.689 7.712 74 7.736 rBB 0.024 1 7.72 7.744 75 7.925 rBV 0.031 4 7.909 7.941 76 7.948 rVB 0.024 3 7.941 7.964 77 7.98 rBB 0.047 3 7.964 8.011 78 8.027 rBV 0.039 4 8.011 8.051

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    79 8.114 rBB 0.031 1 8.106 8.137 80 8.161 rVB 0.039 4 8.137 8.176 81 8.184 rBV 0.047 5 8.176 8.224 82 8.279 rBB 0.063 7 8.263 8.326 83 8.342 rBV 0.031 2 8.326 8.357 84 8.381 rVB 0.031 2 8.373 8.405 85 8.428 rBV 0.024 1 8.42 8.444 86 8.491 rBB 0.031 2 8.483 8.515 87 8.554 rBB 0.047 3 8.53 8.578 88 8.586 rBB 0.031 1 8.578 8.609 89 8.641 rBB 0.039 2 8.609 8.648 90 8.656 rBB 0.031 2 8.648 8.68 91 8.735 rBV 0.205 1257 8.68 8.884 92 9.105 rVB 0.055 8 9.089 9.144 93 9.805 rBV 0.047 6 9.781 9.828 94 10.001 rBV 0.031 3 9.986 10.017

    GCMS Date ran

    Sequence name File Name

    Name Brand (Lot#)

    NDMA per tablet above control (ng)

    18

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    02001020

    Ranitidine (1x 150 mg tablet)

    Zantac (7702406A)

    (Area:2680878) 2978551

    19

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    01801018

    Nizatidine (1x 150 mg capsule)

    Axid (1290625A)

    (Area: 36867) 41693

    20

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    02201022

    Cimetidine (1X 200 mg tablet)

    Tagamet (9AE2576)

    Not Detected

    21

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    01401014

    Famotidine (2x 40 mg tablets)

    Pepcid (1805012732)

    Not Detected

    22

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    01001010

    Omeprazole (2x 40 mg capsule)

    Prilosec (19182878)

    Not Detected

    23

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    01201012

    Esomeprazole (2x 40 mg capsule)

    Nexium (C806922)

    Not Detected

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    24

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    00601006

    Lansoprazole (3x 30 mg capsule)

    Prevacid (C807365)

    Not Detected

    25

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    00801008

    Pantoprazole (2x 40 mg tablets)

    Protonix (PAN18101)

    Not Detected

    26

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    00401004

    Rabeprazole (4x 20 mg capsules)

    AcipHex (BY33E009)

    Not Detected

    27

    EX_GCMS

    20190413

    20190413_RANITIDINE_STUDY_OTC_RUN_2

    01601016

    Dexlansoprazole (2x 60 mg capsule)

    Dexilant (A27540)

    Not Detected

    18.

    Ion 74.00 (73.70 to 74.70): 02001020.D\data.ms 20190412_9

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.157 rVB 0.055 6 3.134 3.189 2 3.213 rBB 0.063 5 3.189 3.252 3 3.26 rBB 0.047 2 3.252 3.299 4 3.386 rVB 0.055 4 3.378 3.433 5 3.496 rBB 0.079 7 3.449 3.527 6 3.574 rVV 0.039 4 3.567 3.606 7 3.614 rVB 0.039 3 3.606 3.645 8 3.653 rBB 0.039 2 3.645 3.685 9 3.747 rBB 0.047 2 3.732 3.779 10 3.85 rBV 0.094 10 3.779 3.873 11 3.905 rVB 0.039 2 3.889 3.928 12 3.952 rBV 0.024 2 3.936 3.96 13 3.991 rVB 0.094 91 3.968 4.062

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    14 4.07 rBB 0.047 3 4.062 4.109 15 4.196 rBV 0.094 12 4.141 4.235 16 4.337 rBV 0.102 36 4.298 4.4 17 4.416 rVB 0.063 5 4.408 4.471 18 4.479 rVB 0.031 2 4.471 4.503 19 4.518 rBV 0.047 4 4.503 4.55 20 4.566 rVB 0.039 3 4.558 4.597 21 4.66 rBV 0.11 12 4.597 4.707 22 4.731 rBB 0.055 2 4.707 4.762 23 4.825 rBB 0.11 38 4.762 4.872 24 4.88 rBB 0.047 3 4.872 4.919 25 4.927 rBB 0.039 1 4.919 4.959 26 5.006 rBV 0.071 5 4.959 5.03 27 5.108 rBV 0.047 3 5.077 5.124 28 5.155 rVB 0.031 2 5.148 5.179 29 5.218 rBV 0.055 6 5.179 5.234 30 5.321 rBV 0.385 2680878 5.234 5.62 31 5.643 rVV 0.244 4452 5.62 5.863 32 5.887 rVB 0.346 1059 5.863 6.21 33 6.949 rVB 0.094 65 6.925 7.02 34 7.201 rBV 0.212 1205 7.161 7.374 35 7.783 rVB 0.134 51 7.759 7.893 36 7.972 rVB 0.071 32 7.948 8.019 37 8.428 rBV 0.189 949 8.294 8.483 38 8.821 rBV 0.181 627 8.656 8.837 39 10.135 rVB 0.102 215 10.111 10.213 40 11.094 rBV 0.173 2349 11.055 11.228

    19.

    Ion 74.00 (73.70 to 74.70): 01801018.D\data.ms 20190412_8

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.15 rVB 0.047 4 3.142 3.189

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    2 3.228 rVB 0.094 12 3.213 3.307 3 3.315 rBB 0.047 1 3.307 3.354 4 3.409 rBB 0.087 5 3.37 3.456 5 3.496 rVB 0.063 7 3.464 3.527 6 3.567 rBB 0.047 3 3.527 3.574 7 3.59 rBB 0.079 3 3.574 3.653 8 3.677 rVB 0.031 2 3.661 3.692 9 3.732 rBV 0.031 3 3.716 3.747 10 3.755 rBB 0.031 1 3.747 3.779 11 3.834 rBB 0.024 1 3.818 3.842 12 3.858 rBB 0.071 5 3.842 3.913 13 3.991 rBB 0.071 48 3.952 4.023 14 4.094 rBB 0.031 1 4.086 4.117 15 4.188 rBV 0.071 13 4.157 4.227 16 4.251 rBB 0.039 2 4.227 4.267 17 4.345 rBV 0.149 38 4.267 4.416 18 4.44 rVB 0.071 14 4.416 4.487 19 4.511 rBV 0.047 6 4.487 4.534 20 4.581 rBB 0.039 2 4.573 4.613 21 4.802 rBB 0.126 23 4.746 4.872 22 4.904 rBV 0.047 5 4.872 4.92 23 4.935 rBB 0.031 1 4.927 4.959 24 4.967 rBV 0.024 2 4.959 4.982 25 5.1 rBV 0.024 2 5.085 5.108 26 5.124 rVB 0.031 3 5.116 5.148 27 5.203 rVV 0.047 7 5.179 5.226 28 5.234 rVV 0.031 7 5.226 5.258 29 5.313 rVV 0.323 36867 5.274 5.596 30 5.643 rVB 0.197 912 5.596 5.793 31 5.887 rBV 0.055 59 5.863 5.919 32 6.084 rBV 0.047 7 6.068 6.115 33 6.359 rBV 0.047 4 6.32 6.367 34 6.485 rBV 0.087 24 6.406 6.493 35 6.626 rBV 0.055 17 6.603 6.658 36 6.831 rVB 0.047 10 6.807 6.855 37 6.957 rBV 0.055 48 6.925 6.98 38 7.004 rVB 0.039 11 6.988 7.028 39 7.24 rBV 0.063 15 7.216 7.279 40 7.531 rBV 0.063 132 7.5 7.563 41 7.578 rVB 0.063 28 7.563 7.625 42 7.696 rVB 0.071 17 7.673 7.743

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    43 7.791 rBV 0.087 47 7.759 7.846 44 7.979 rVB 0.118 62 7.901 8.019 45 8.428 rBV 0.228 1256 8.247 8.475 46 8.829 rBV 0.181 586 8.656 8.837 47 9.222 rVB 0.094 516 9.191 9.285 48 10.135 rVB 0.102 529 10.103 10.206 49 11.094 rBV 0.173 11454 11.047 11.22 50 11.252 rVB 0.228 731 11.228 11.456 51 11.818 rVB 0.094 108 11.795 11.889 52 12.605 rVB 0.055 46 12.589 12.644 53 13.533 rVB 0.071 211 13.494 13.564 54 13.619 rVB 0.236 333 13.58 13.816 55 14.076 rVB 0.165 295 14.044 14.209

    20.

    Ion 74.00 (73.70 to 74.70): 02201022.D\data.ms 20190412_10

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.346 rBV 0.055 4 3.307 3.362 2 3.488 rBB 0.094 9 3.457 3.551 3 3.575 rBB 0.071 4 3.551 3.622 4 3.645 rBV 0.039 2 3.622 3.661 5 3.724 rBB 0.031 1 3.716 3.748 6 3.771 rBB 0.047 2 3.748 3.795 7 3.85 rBV 0.071 14 3.811 3.881

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    8 3.991 rVB 0.071 10 3.96 4.031 9 4.039 rBV 0.031 3 4.031 4.062 10 4.07 rBB 0.055 3 4.062 4.117 11 4.125 rBB 0.031 1 4.117 4.149 12 4.165 rBV 0.024 2 4.149 4.172 13 4.196 rBB 0.047 6 4.18 4.227 14 4.345 rBV 0.134 60 4.298 4.432 15 4.503 rBB 0.055 2 4.495 4.55 16 4.574 rBB 0.047 1 4.566 4.613 17 4.636 rBB 0.047 3 4.613 4.66 18 4.794 rBV 0.087 22 4.739 4.825 19 4.896 rBB 0.039 2 4.888 4.928 20 4.951 rBV 0.039 3 4.928 4.967 21 5.014 rBV 0.031 2 4.998 5.03 22 5.242 rBB 0.055 5 5.219 5.274 23 5.313 rBV 0.055 20 5.289 5.344 24 5.486 rBB 0.063 4 5.478 5.541 25 5.549 rBV 0.039 4 5.541 5.58 26 5.643 rVV 0.11 45 5.596 5.706 27 5.73 rVV 0.024 3 5.722 5.746 28 5.761 rVB 0.079 6 5.746 5.824 29 5.84 rBB 0.031 1 5.832 5.864 30 5.879 rBV 0.039 5 5.871 5.911 31 5.927 rVB 0.047 4 5.919 5.966 32 6.092 rBV 0.26 409 6.045 6.304 33 6.8 rVB 0.071 12 6.792 6.863 34 6.957 rVB 0.071 40 6.926 6.996 35 7.012 rBB 0.031 2 7.004 7.036 36 7.067 rBV 0.031 4 7.059 7.091 37 7.169 rBV 0.031 5 7.162 7.193 38 7.24 rVB 0.094 22 7.224 7.319 39 7.594 rBV 0.055 9 7.563 7.618 40 7.783 rBB 0.087 37 7.759 7.846 41 7.917 rBV 0.031 6 7.901 7.932 42 7.964 rVB 0.055 15 7.948 8.003 43 8.428 rBV 0.205 1136 8.279 8.483 44 10.143 rVB 0.33 1617 10.111 10.442 45 11.008 rVB 0.063 89 10.977 11.04 46 11.095 rVV 0.165 3436 11.055 11.22 47 11.244 rVB 0.173 287 11.22 11.393 48 11.488 rBV 0.063 140 11.456 11.519

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    49 11.81 rBV 0.055 52 11.787 11.842 50 13.62 rVB 0.149 172 13.58 13.73 51 14.485 rBV 0.094 118 14.453 14.548

    21.

    Ion 74.00 (73.70 to 74.70): 01401014.D\data.ms 20190412_6

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.386 rBV 0.071 8 3.339 3.409 2 3.433 rVB 0.024 1 3.417 3.441 3 3.457 rBV 0.024 2 3.441 3.464 4 3.488 rVB 0.087 9 3.472 3.559 5 3.622 rBB 0.055 3 3.582 3.637 6 3.645 rBB 0.063 3 3.637 3.7 7 3.716 rBB 0.031 2 3.708 3.74 8 3.748 rBB 0.031 1 3.74 3.771 9 3.803 rBB 0.031 1 3.795 3.826 10 3.85 rBV 0.11 11 3.826 3.936 11 3.991 rVB 0.047 4 3.976 4.023 12 4.047 rBB 0.047 2 4.031 4.078 13 4.196 rBB 0.094 10 4.149 4.243

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    14 4.338 rBV 0.22 48 4.29 4.511 15 4.534 rVB 0.039 2 4.518 4.558 16 4.566 rBB 0.031 1 4.558 4.589 17 4.613 rBB 0.047 2 4.589 4.636 18 4.786 rVB 0.102 7 4.77 4.872 19 4.88 rBB 0.047 2 4.872 4.92 20 4.928 rBB 0.055 2 4.92 4.975 21 4.99 rBV 0.031 2 4.975 5.006 22 5.014 rVB 0.031 2 5.006 5.038 23 5.045 rBB 0.102 6 5.038 5.14 24 5.211 rBV 0.094 8 5.187 5.281 25 5.36 rVB 0.024 1 5.352 5.376 26 5.392 rBB 0.039 2 5.376 5.415 27 5.431 rBB 0.055 5 5.415 5.47 28 5.612 rBV 0.047 7 5.588 5.635 29 5.659 rVB 0.063 7 5.643 5.706 30 5.73 rBB 0.047 2 5.714 5.761 31 5.934 rVB 0.142 18 5.887 6.029 32 6.092 rBV 0.338 452 6.029 6.367 33 6.446 rBB 0.063 5 6.422 6.485 34 6.572 rBB 0.039 3 6.548 6.587 35 6.634 rBV 0.071 11 6.587 6.658 36 6.91 rBV 0.031 2 6.886 6.918 37 6.957 rVB 0.071 29 6.925 6.996 38 7.075 rVB 0.024 2 7.059 7.083 39 7.248 rBV 0.11 36 7.201 7.311 40 7.523 rBV 0.016 1 7.515 7.531 41 7.602 rBV 0.126 21 7.555 7.681 42 7.791 rBB 0.11 42 7.759 7.869 43 8.334 rBV 0.055 17 8.294 8.349 44 8.428 rBV 0.118 710 8.357 8.475 45 8.75 rBV 0.126 354 8.656 8.782 46 11.095 rVB 0.275 1766 11.063 11.338 47 11.425 rVB 0.071 56 11.393 11.464 48 13.533 rVB 0.055 54 13.517 13.572 49 14.493 rBV 0.094 188 14.445 14.54 50 14.571 rVB 0.094 173 14.54 14.634

    22.

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    Ion 74.00 (73.70 to 74.70): 01001010.D\data.ms 20190412_4

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.252 rVB 0.039 3 3.244 3.284 2 3.339 rBV 0.055 5 3.331 3.386 3 3.409 rVB 0.024 1 3.401 3.425 4 3.433 rBB 0.031 1 3.425 3.457 5 3.488 rBB 0.087 8 3.464 3.551 6 3.582 rBB 0.055 3 3.559 3.614 7 3.685 rVB 0.047 3 3.669 3.716 8 3.748 rBB 0.031 1 3.74 3.771 9 3.842 rVV 0.126 17 3.811 3.936 10 3.991 rVV 0.094 144 3.944 4.039 11 4.054 rVB 0.055 4 4.047 4.102 12 4.109 rBB 0.047 4 4.102 4.149 13 4.204 rBV 0.118 26 4.149 4.267 14 4.345 rBV 0.126 65 4.275 4.4 15 4.424 rVB 0.118 28 4.4 4.518 16 4.636 rBV 0.047 5 4.629 4.676 17 4.692 rVV 0.047 4 4.684 4.731 18 4.825 rVB 0.157 52 4.739 4.896 19 4.959 rBV 0.024 2 4.951 4.975 20 5.046 rVB 0.071 7 5.022 5.093 21 5.108 rBB 0.031 1 5.101 5.132 22 5.156 rBB 0.047 2 5.132 5.179 23 5.226 rBV 0.031 2 5.211 5.242 24 5.305 rBV 0.047 3 5.274 5.321 25 5.431 rVB 0.055 3 5.423 5.478

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    26 5.557 rBV 0.063 6 5.51 5.573 27 5.612 rBV 0.055 54 5.588 5.643 28 5.73 rVB 0.071 7 5.706 5.777 29 5.801 rBB 0.031 1 5.793 5.824 30 5.832 rBB 0.039 2 5.824 5.864 31 5.879 rBV 0.031 2 5.864 5.895 32 5.934 rBB 0.126 18 5.903 6.029 33 6.068 rBB 0.047 1 6.06 6.107 34 6.162 rBB 0.079 5 6.107 6.186 35 6.218 rBV 0.055 6 6.186 6.241 36 6.28 rBV 0.047 5 6.265 6.312 37 6.367 rVB 0.055 8 6.343 6.398 38 6.446 rBV 0.055 6 6.398 6.454 39 6.634 rBV 0.126 30 6.564 6.69 40 6.76 rBV 0.039 6 6.745 6.784 41 6.957 rVB 0.102 309 6.918 7.02 42 7.083 rBB 0.063 6 7.051 7.114 43 7.13 rBB 0.047 3 7.114 7.161 44 7.24 rBV 0.118 51 7.201 7.319 45 7.335 rVB 0.047 5 7.327 7.374 46 7.594 rBV 0.165 214 7.555 7.72 47 7.791 rBV 0.142 63 7.736 7.877 48 8.208 rBB 0.039 5 8.2 8.239 49 8.326 rBV 0.102 30 8.247 8.349 50 8.428 rBV 0.134 786 8.349 8.483 51 8.829 rBV 0.197 631 8.656 8.853 52 11.095 rBV 0.134 636 11.063 11.197 53 14.485 rBV 0.094 357 14.445 14.54 54 14.571 rVB 0.094 242 14.54 14.634

    23.

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    Ion 74.00 (73.70 to 74.70): 01201012.D\data.ms 20190412_5

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.228 rBB 0.039 2 3.221 3.26 2 3.276 rVB 0.031 2 3.268 3.299 3 3.346 rBV 0.031 2 3.323 3.354 4 3.37 rBB 0.047 2 3.362 3.409 5 3.488 rVB 0.087 14 3.449 3.535 6 3.551 rBV 0.024 2 3.535 3.559 7 3.59 rVB 0.047 4 3.567 3.614 8 3.661 rBB 0.047 1 3.645 3.693 9 3.716 rVB 0.047 3 3.7 3.748 10 3.771 rBB 0.063 4 3.748 3.811 11 3.85 rBV 0.094 13 3.811 3.905 12 3.929 rVB 0.031 2 3.913 3.944 13 3.991 rBB 0.102 78 3.944 4.047 14 4.117 rVB 0.047 3 4.102 4.149 15 4.196 rBV 0.094 68 4.149 4.243 16 4.338 rBV 0.173 195 4.29 4.463 17 4.589 rBB 0.031 1 4.581 4.613 18 4.636 rBB 0.055 3 4.613 4.668 19 4.731 rBV 0.024 2 4.723 4.747 20 4.817 rVV 0.126 72 4.747 4.872 21 4.88 rBB 0.039 1 4.872 4.912 22 4.99 rVB 0.039 3 4.983 5.022 23 5.03 rBV 0.039 4 5.022 5.061 24 5.101 rBB 0.102 2 5.085 5.187 25 5.226 rBB 0.063 5 5.195 5.258 26 5.313 rBV 0.055 4 5.282 5.337 27 5.439 rVB 0.039 3 5.415 5.455 28 5.533 rBV 0.055 5 5.517 5.573 29 5.612 rVV 0.055 50 5.58 5.635 30 5.651 rVV 0.071 33 5.635 5.706 31 5.73 rVB 0.047 7 5.714 5.761

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    32 5.785 rBB 0.031 2 5.769 5.801 33 5.879 rBB 0.087 5 5.809 5.895 34 5.934 rBB 0.094 17 5.895 5.989 35 5.997 rBB 0.055 3 5.989 6.045 36 6.068 rBB 0.031 2 6.045 6.076 37 6.092 rBV 0.031 3 6.076 6.107 38 6.139 rBV 0.047 3 6.107 6.155 39 6.21 rBV 0.031 3 6.194 6.225 40 6.241 rVB 0.071 7 6.233 6.304 41 6.359 rBV 0.031 3 6.343 6.375 42 6.438 rBV 0.047 4 6.414 6.461 43 6.501 rBB 0.047 3 6.493 6.54 44 6.556 rBV 0.039 5 6.54 6.579 45 6.634 rBV 0.079 15 6.579 6.658 46 6.713 rBV 0.024 2 6.697 6.721 47 6.76 rBB 0.031 2 6.752 6.784 48 6.957 rBV 0.11 394 6.902 7.012 49 7.091 rBV 0.071 19 7.036 7.106 50 7.374 rVV 0.346 997 7.217 7.563 51 7.594 rVB 0.102 138 7.563 7.665 52 7.791 rBV 0.071 29 7.759 7.83 53 7.964 rBV 0.102 61 7.893 7.995 54 8.027 rVB 0.071 145 7.995 8.066 55 8.326 rBV 0.063 32 8.286 8.349 56 8.428 rBV 0.157 1004 8.349 8.507 57 8.79 rVB 0.307 1532 8.656 8.963 58 9.207 rBV 0.047 24 9.191 9.238 59 9.773 rBV 0.102 62 9.734 9.836 60 9.867 rVV 0.055 24 9.844 9.899 61 9.962 rVV 0.079 113 9.915 9.993 62 10.033 rVV 0.079 122 10.001 10.08 63 10.119 rVB 0.149 267 10.08 10.229 64 10.654 rVB 0.047 18 10.638 10.686 65 10.78 rVB 0.126 73 10.748 10.874 66 11.087 rBV 0.173 2516 11.039 11.213 67 11.236 rVB 0.149 153 11.213 11.362 68 11.417 rBV 0.047 36 11.393 11.441 69 11.504 rBV 0.228 921 11.449 11.677 70 11.858 rBV 0.079 106 11.826 11.905 71 12.117 rVB 0.071 32 12.094 12.164 72 13.934 rBV 0.157 251 13.879 14.036

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    73 14.571 rBV 0.063 60 14.548 14.611

    24.

    Ion 74.00 (73.70 to 74.70): 00601006.D\data.ms 20190412_2

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.37 rBV 0.047 6 3.338 3.386 2 3.417 rBV 0.047 3 3.386 3.433 3 3.496 rVB 0.071 8 3.472 3.543 4 3.551 rBB 0.039 1 3.543 3.582 5 3.653 rBB 0.039 2 3.645 3.685 6 3.716 rBB 0.047 2 3.708 3.755 7 3.779 rBB 0.055 3 3.755 3.81 8 3.85 rBB 0.087 10 3.81 3.897 9 3.913 rBB 0.039 2 3.897 3.936 10 3.991 rBB 0.071 5 3.96 4.031 11 4.039 rBB 0.039 1 4.031 4.07 12 4.078 rBB 0.047 1 4.07 4.117 13 4.204 rBB 0.142 156 4.141 4.282 14 4.345 rBV 0.118 103 4.282 4.4 15 4.424 rVB 0.102 37 4.4 4.503 16 4.636 rBB 0.039 1 4.628 4.668 17 4.746 rBB 0.039 1 4.731 4.77 18 4.794 rBB 0.039 4 4.778 4.817 19 4.841 rVB 0.063 5 4.833 4.896 20 4.935 rBB 0.031 2 4.92 4.951 21 4.967 rBV 0.031 2 4.951 4.982

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    22 5.03 rBB 0.063 3 4.99 5.053 23 5.132 rVB 0.055 6 5.1 5.155 24 5.163 rBV 0.031 3 5.155 5.187 25 5.226 rBV 0.055 7 5.195 5.25 26 5.305 rVB 0.039 2 5.297 5.336 27 5.344 rBB 0.039 2 5.336 5.376 28 5.439 rBB 0.047 2 5.415 5.462 29 5.557 rBB 0.063 37 5.525 5.588 30 5.62 rBV 0.055 105 5.588 5.643 31 5.808 rBB 0.031 1 5.801 5.832 32 5.887 rBV 0.024 2 5.879 5.903 33 5.942 rVV 0.094 71 5.911 6.005 34 6.021 rVV 0.031 4 6.013 6.044 35 6.076 rVV 0.047 5 6.052 6.099 36 6.139 rBB 0.047 4 6.123 6.17 37 6.225 rVB 0.047 4 6.217 6.265 38 6.28 rBV 0.047 3 6.265 6.312 39 6.422 rBV 0.039 5 6.398 6.438 40 6.446 rVB 0.094 5 6.438 6.532 41 6.556 rBV 0.024 2 6.548 6.571 42 6.634 rVV 0.055 8 6.611 6.666 43 6.689 rVB 0.039 5 6.666 6.705 44 6.815 rVB 0.039 6 6.8 6.839 45 6.957 rBV 0.102 1087 6.917 7.02 46 7.059 rBV 0.039 3 7.035 7.075 47 7.256 rBV 0.11 84 7.201 7.311 48 7.342 rVB 0.079 37 7.319 7.397 49 7.594 rVB 0.118 21 7.57 7.688 50 7.783 rBV 0.094 41 7.751 7.846 51 7.861 rVB 0.039 4 7.846 7.885 52 7.909 rBB 0.055 6 7.893 7.948 53 8.027 rBB 0.126 124 7.987 8.113 54 8.341 rBV 0.047 20 8.31 8.357 55 8.428 rBV 0.11 666 8.365 8.475 56 10.166 rVB 0.071 205 10.135 10.206 57 11.094 rBV 0.157 412 11.063 11.22 58 11.488 rBV 0.055 55 11.456 11.511 59 11.543 rBV 0.087 84 11.519 11.606 60 12.801 rBV 0.063 152 12.77 12.833 61 13.132 rBB 0.118 595 13.108 13.226 62 13.934 rBV 0.149 356 13.879 14.028

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    63 14.493 rBV 0.094 170 14.453 14.548

    25.

    Ion 74.00 (73.70 to 74.70): 00801008.D\data.ms 20190412_3

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.386 rBB 0.055 2 3.378 3.433 2 3.488 rVB 0.039 5 3.472 3.512 3 3.535 rBB 0.039 2 3.512 3.551 4 3.582 rVB 0.079 22 3.559 3.637 5 3.653 rBV 0.047 4 3.637 3.685 6 3.716 rVB 0.024 2 3.708 3.732 7 3.755 rBV 0.031 2 3.732 3.763 8 3.779 rBB 0.031 1 3.771 3.803 9 3.85 rBV 0.055 11 3.818 3.873 10 3.991 rBB 0.11 816 3.96 4.07 11 4.102 rBV 0.063 5 4.094 4.157 12 4.196 rBB 0.094 10 4.165 4.259 13 4.275 rVB 0.031 2 4.267 4.298 14 4.338 rBV 0.236 273 4.298 4.534 15 4.676 rBV 0.024 2 4.668 4.692 16 4.77 rBB 0.087 40 4.747 4.833 17 4.857 rVB 0.039 2 4.849 4.888 18 4.92 rBB 0.047 2 4.896 4.943 19 5.014 rBB 0.063 4 4.983 5.046 20 5.226 rBB 0.071 6 5.195 5.266 21 5.352 rBB 0.047 2 5.337 5.384

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    22 5.439 rBB 0.071 4 5.392 5.462 23 5.517 rBB 0.039 2 5.502 5.541 24 5.557 rBB 0.047 4 5.541 5.588 25 5.612 rBV 0.039 8 5.588 5.628 26 5.659 rVB 0.087 20 5.628 5.714 27 5.746 rVB 0.094 8 5.714 5.809 28 5.824 rBB 0.039 2 5.816 5.856 29 5.871 rBV 0.031 3 5.864 5.895 30 5.934 rBB 0.087 9 5.911 5.997 31 6.092 rBV 0.291 589 6.044 6.336 32 6.634 rBB 0.102 14 6.595 6.697 33 6.957 rVB 0.087 60 6.91 6.996 34 7.067 rBB 0.039 2 7.051 7.091 35 7.24 rBV 0.094 25 7.217 7.311 36 7.594 rVB 0.094 15 7.578 7.673 37 7.799 rBB 0.118 35 7.744 7.862 38 8.027 rBB 0.079 78 8.003 8.082 39 8.334 rBV 0.039 13 8.31 8.349 40 8.428 rBV 0.11 685 8.365 8.475 41 10.143 rBV 0.071 197 10.111 10.182 42 11.095 rBV 0.181 4916 11.047 11.228 43 11.244 rVB 0.22 416 11.228 11.449 44 11.488 rBB 0.063 33 11.464 11.527 45 13.132 rBV 0.055 98 13.108 13.163 46 13.934 rBV 0.157 328 13.879 14.036 47 14.485 rBV 0.087 133 14.453 14.54

    26.

    Ion 74.00 (73.70 to 74.70): 00401004.D\data.ms

  • Confidential Information: This information should not be reproduced without written approval from Valisure LLC.

    20190412_1

    Peak # Ret Time Type Width Area Start Time

    End Time

    1 3.252 rVB 0.055 7 3.236 3.291 2 3.323 rBB 0.039 1 3.315 3.354 3 3.496 rBB 0.071 7 3.464 3.535 4 3.59 rBB 0.047 1 3.582 3.63 5 3.685 rVB 0.047 3 3.669 3.716 6 3.724 rBB 0.055 2 3.716 3.771 7 3.787 rBB 0.031 1 3.779 3.811 8 3.85 rBV 0.094 11 3.811 3.905 9 3.991 rVB 0.055 8 3.976 4.031 10 4.047 rBB 0.11 6 4.039 4.149 11 4.188 rBV 0.102 11 4.149 4.251 12 4.338 rBV 0.26 243 4.275 4.534 13 4.66 rBV 0.079 7 4.605 4.684 14 4.707 rVB 0.055 5 4.692 4.747 15 4.794 rBB 0.11 30 4.747 4.857 16 4.943 rBB 0.039 2 4.92 4.959 17 4.99 rBB 0.047 4 4.967 5.014 18 5.077 rBV 0.189 849 5.022 5.211 19 5.36 rBB 0.079 6 5.344 5.423 20 5.62 rBV 0.031 8 5.596 5.628 21 5.651 rVB 0.063 13 5.636 5.698 22 5.73 rBB 0.047 3 5.698 5.746 23 5.761 rBB 0.031 2 5.753 5.785 24 5.879 rBB 0.047 4 5.871 5.919 25 5.927 rBV 0.024 3 5.919 5.942 26 5.958 rVB 0.031 3 5.942 5.974 27 5.997 rBB 0.071 3 5.974 6.045 28 6.092 rBV 0.173 359 6.052 6.225 29 6.422 rBV 0.039 3 6.406 6.446 30 6.572 rBV 0.031 3 6.556 6.587 31 6.627 rBV 0.063 11 6.611 6.674 32 6.957 rVB 0.071 26 6.926 6.996 33 7.248 rBV 0.102 21 7.201 7.303 34 7.421 rBB 0.039 5 7.405 7.445 35 7.531 rVB 0.055 12 7.508 7.563 36 7.602 rBV 0.094 25 7.563 7.657 37 7.783 rBV 0.102 50 7.751 7.854 38 8.027 rBV 0.087 34 7.995 8.082

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    39 8.349 rBV 0.047 27 8.326 8.373 40 8.428 rBV 0.126 745 8.373 8.499 41 8.75 rBV 0.102 468 8.664 8.766 42 9.23 rVB 0.079 151 9.207 9.285 43 10.143 rBV 0.087 196 10.103 10.19 44 11.095 rBV 0.094 259 11.071 11.165 45 11.291 rVB 0.165 358 11.244 11.409 46 11.48 rBB 0.063 80 11.456 11.519 47 13.313 rBV 0.071 142 13.25 13.321 48 13.95 rVB 0.142 312 13.895 14.036

    27.

    Ion 74.00 (73.70 to 74.70): 01601016.D\data.ms 20190412_7

    Peak # Ret Time Type Width Area Start

    Time End Time

    1 3.181 rVB 0.087 25 3.15 3.236 2 3.252 rBB 0.039 3 3.236 3.276 3 3.291 rBB 0.047 3 3.284 3.331 4 3.394 rBV 0.071 17 3.331 3.402 5 3.496 rVB 0.071 16 3.464 3.535 6 3.582 rBB 0.039 1 3.575 3.614

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    7 3.645 rVB 0.039 4 3.63 3.669 8 3.677 rBB 0.055 3 3.669 3.724 9 3.74 rBB 0.024 1 3.724 3.748 10 3.787 rBV 0.071 16 3.748 3.818 11 3.85 rBB 0.079 53 3.818 3.897 12 3.913 rVB 0.039 4 3.897 3.936 13 3.944 rBV 0.024 2 3.936 3.96 14 3.992 rVV 0.055 8 3.96 4.015 15 4.031 rVB 0.031 2 4.023 4.054 16 4.141 rBB 0.024 1 4.125 4.149 17 4.204 rBV 0.118 108 4.149 4.267 18 4.345 rVB 0.275 155 4.298 4.574 19 4.637 rBV 0.047 7 4.621 4.668 20 4.684 rVB 0.055 6 4.676 4.731 21 4.739 rBV 0.024 2 4.731 4.755 22 4.794 rVB 0.071 12 4.762 4.833 23 4.935 rBV 0.047 5 4.928 4.975 24 4.983 rVB 0.047 3 4.975 5.022 25 5.085 rVB 0.055 6 5.053 5.108 26 5.148 rBB 0.039 2 5.124 5.164 27 5.226 rBB 0.094 8 5.164 5.258 28 5.266 rBB 0.039 3 5.258 5.297 29 5.321 rBV 0.031 2 5.297 5.329 30 5.36 rVB 0.071 5 5.344 5.415 31 5.439 rBB 0.063 3 5.423 5.486 32 5.557 rBV 0.071 79 5.518 5.588 33 5.62 rBV 0.055 61 5.588 5.643 34 5.659 rVB 0.071 32 5.643 5.714 35 5.73 rVB 0.047 4 5.714 5.761 36 5.769 rBB 0.039 3 5.761 5.801 37 5.809 rBB 0.031 1 5.801 5.832 38 5.942 rBV 0.165 35 5.832 5.997 39 6.013 rBB 0.039 2 6.005 6.045 40 6.084 rBV 0.047 19 6.052 6.1 41 6.343 rBB 0.047 3 6.336 6.383 42 6.454 rBV 0.079 14 6.414 6.493 43 6.54 rBB 0.024 1 6.524 6.548 44 6.587 rBV 0.031 4 6.564 6.595 45 6.635 rBV 0.055 9 6.603 6.658 46 6.69 rBV 0.047 10 6.658 6.705 47 6.815 rVB 0.047 7 6.808 6.855

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    48 6.957 rVB 0.11 585 6.918 7.028 49 7.067 rBV 0.126 47 7.028 7.154 50 7.248 rBV 0.142 166 7.177 7.319 51 7.531 rVB 0.047 14 7.508 7.555 52 7.586 rVB 0.071 13 7.563 7.634 53 7.791 rBV 0.087 41 7.751 7.838 54 7.862 rVB 0.055 14 7.838 7.893 55 8.035 rBB 0.087 126 7.995 8.082 56 8.326 rBV 0.063 30 8.286 8.349 57 8.428 rBV 0.11 685 8.365 8.475 58 8.79 rBV 0.149 452 8.656 8.806 59 10.166 rVB 0.094 153 10.135 10.229 60 11.095 rBV 0.126 402 11.063 11.189