laboratories pvt ltd › docs › sumalabs_impurities.pdf · carvedilol usp-a carvedilol ep...

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LABORATORIES PVT LTD Suma Laboratories ® All rights reserved S.No. Name of the compound CAS Structure Remarks 001 1-(9H-carbazol-4-yloxy)-3-[2-(2- methoxyphenoxy)ethylamino]propan-2-ol C24H26N2O4 M.Wt.: 406.47 72956-09-3 Carvedilol 002 4-(oxiran-2-ylmethoxy)-9H-carbazole C15H13NO2 M.Wt.: 239.27 51997-51-4 Carvedilol related compound Carvedilol USP-D 003 1-(9H-carbazol-4-yloxy)-3-[2-(2- methoxyphenoxy)ethyl-propan-2- ylamino]propan-2-ol C27H32 N2O4 M.Wt.: 448.5 1246819-01-1 N-Isopropyl Carvedilol Carvedilol related compound 004 2-(2-methoxyphenoxy)ethanamine C9H13NO2 M.Wt.: 167.21 1836-62-0 Carvedilol USP-A 005 1-[4-[2-hydroxy-3-[2-(2- methoxyphenoxy)ethylamino]propoxy]car bazol-9-yl]-3-[2-(2- methoxyphenoxy)ethylamino]propan-2-ol C36H43N3O7 M.Wt: : 629.74 1198090-73-1 Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H- carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2- methoxyphenoxy)ethyl]amino]propan-2-ol C39H39N3O6 M.Wt: 645.74 918903-20-5 Carvedilol USP-B Carvedilol EP Impurity B 007 1-[benzyl-[2-(2- methoxyphenoxy)ethyl]amino]-3-(9H- carbazol-4-yloxy)propan-2-ol C31H32N2O4 M.Wt. 496.60 72955-94-3 N-Benzyl Carvedilol Carvedilol EP Impurity C; Carvedilol Impurity C; Carvedilol USP-C

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Page 1: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

LABORATORIES PVT LTD

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S.No. Name of the compound CAS Structure Remarks

001 1-(9H-carbazol-4-yloxy)-3-[2-(2-

methoxyphenoxy)ethylamino]propan-2-ol

C24H26N2O4

M.Wt.: 406.47

72956-09-3

Carvedilol

002 4-(oxiran-2-ylmethoxy)-9H-carbazole

C15H13NO2

M.Wt.: 239.27

51997-51-4

Carvedilol related compound

Carvedilol USP-D

003 1-(9H-carbazol-4-yloxy)-3-[2-(2-

methoxyphenoxy)ethyl-propan-2-

ylamino]propan-2-ol

C27H32 N2O4

M.Wt.: 448.5

1246819-01-1

N-Isopropyl Carvedilol

Carvedilol related compound

004 2-(2-methoxyphenoxy)ethanamine

C9H13NO2

M.Wt.: 167.21

1836-62-0

Carvedilol USP-A

005 1-[4-[2-hydroxy-3-[2-(2-

methoxyphenoxy)ethylamino]propoxy]car

bazol-9-yl]-3-[2-(2-

methoxyphenoxy)ethylamino]propan-2-ol

C36H43N3O7

M.Wt: : 629.74

1198090-73-1

Carvedilol USP-A

Carvedilol EP Impurity A

006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-

carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-

methoxyphenoxy)ethyl]amino]propan-2-ol

C39H39N3O6

M.Wt: 645.74

918903-20-5

Carvedilol USP-B

Carvedilol EP Impurity B

007 1-[benzyl-[2-(2-

methoxyphenoxy)ethyl]amino]-3-(9H-

carbazol-4-yloxy)propan-2-ol

C31H32N2O4

M.Wt. 496.60

72955-94-3

N-Benzyl Carvedilol

Carvedilol EP Impurity C;

Carvedilol Impurity C; Carvedilol

USP-C

Page 2: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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008

1-[9-[3-(9H-carbazol-4-yloxy)-2-

hydroxypropyl]carbazol-4-yl]oxy-3-[2-(2-

methoxyphenoxy)ethylamino]propan-2-ol

C39H39N3O6

M.Wt: 645.74

1391052-16-6

Carvedilol EP Impurity D

009 1-(9H-carbazol-4-yloxy)-3-[2-[2-[2-[[3-

(9H-carbazol-4-yloxy)-2-

hydroxypropyl]amino]ethoxy]phenoxy]eth

ylamino]propan-2-ol

C40H42N4O6

M.Wt.: 674.78

1346602-98-9

Carvedilol

Bisalkylpyrocatechol

Impurity

Carvedilol related compound

010 2-[2-(cyanomethoxy)phenoxy]acetonitrile 27165-64-6

Carvedilol impurity

011 2-[2-(cyanomethoxy)phenoxy]acetonitrile 27165-64-6

Carvedilol impurity

012 2-(5-methoxy-1H-indol-3-

yl)ethanamine;hydrochloride

Chemical Formula: C11H15ClN2O

MWt.: 226.70

66-83-1

Melatonin Related compound

013 N-[3-(2-formamido-5-methoxyphenyl)-3-

oxopropyl]acetamide

C13H16N2O4

MWt.: 264.28

52450-38-1

Melatonin degradant

014 4-ethyl-3-methyl-N-[2-[4-[(4-

methylcyclohexyl)carbamoylsulfamoyl]phe

nyl]ethyl]-5-oxo-2H-pyrrole-1-

carboxamide

C24H34N4O5S

684286-46-2

Glimepiride cis-isomer

Glimepiride EP Impurity A;

Glimepiride USP-A;

Page 3: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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MWt: 490.62

015 4-ethyl-3-methyl-5-oxo-N-[2-(4-

sulfamoylphenyl)ethyl]-2H-pyrrole-1-

carboxamide

C16H21N3O4S

MWt: 351.42

119018-29-0

Glimepiride sulfonamide

Glimepiride EP Impurity B;

Glimepiride USP-B;

016 Methyl N-[4-[2-[(4-ethyl-3-methyl-5-oxo-

2H-pyrrole-1-

carbonyl)amino]ethyl]phenyl]sulfonylcarb

amateC18H23N3O6S

MWt: 409.46

119018-30-3

Glimepiride urethane

Glimepiride EP Impurity C;

Glimepiride USP-C;

017 4-ethyl-3-methyl-N-[2-[3-[(4-

methylcyclohexyl)carbamoylsulfamoyl]phe

nyl]ethyl]-5-oxo-2H-pyrrole-1-

carboxamide

C24H34N4O5S

MWt: 490.62

791104-62-6

Glimepiride 3-isomer

Glimepiride EP Impurity D;

Glimepiride USP-D;

018 (2R,3S)-5-[3-(tert-butylamino)-2-

hydroxypropoxy]-1,2,3,4-

tetrahydronaphthalene-2,3-diol

C17H27NO4

MWt: 309.40

42200-33-9

Nadolol

019 cis-5-[(2RS)-2,3-Dihydroxypropoxy]-

1,2,3,4-tetrahydronaphtalene-2,3-diol

C13H18O5

MWt: 254.28

NA

Tetraol

Nadolol EP Impurity A; Nadolol

alcohol (USP)

020 cis-5-[(2RS)-2-Hydroxy-3-

methoxypropoxy]-

1,2,3,4-tetrahydronaphtalene-2,3-diol

C14H20O5

MWt: 268.31

NA

Nadolol EP Impurity B; Nadolol

Methoxy analog (USP)

021 5,5' -[(2-Hydroxypropane-1,3-diyl) NA Nadolol EP Impurity C;

Diaryl glycerol analog(USP)

Page 4: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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bis(oxy)]bis(cis-1,2,3,4-

tetrahydronaphthalene-2,3-diol)

C23H28O7

MWt: 416.46

022 5,5' [[(1,1-Dimethylethyl)imino]bis[(2-

hydroxypropane-1,3-diyl)oxy]]bis(cis-

1,2,3,4-tetrahydronaphthalene-2,3-diol)

C30H43NO8

M.Wt: 545.66

67247-26-1

Nadolol EP Impurity D Nadolol

dimer (USP)

023 cis-5-[(2-RS)-3-[(1,1-Dimethylethyl)

amino]-2-hydroxypropoxy]

-8-iodo-1,2,3,4-tetrahydronaphtalene-2,3-

diol

C17H26INO4

M.Wt: 435.3

67247-33-0

Nadolol EP Impurity E

024 1-(tert-butylamino)-3-naphthalen-1-

yloxypropan-2-ol

C17H23NO2

M.Wt: 273.4

2116-22-5

Nadolol EP Impurity F; Naphthyl

analoge(USP)

025 1-(tert-butylamino)-3-(5,6,7,8-

tetrahydronaphthalen-1-yloxy)propan-2-ol

C17H27NO2

M.Wt: 277.4

33841-03-1

De(2,3-dihydroxy)nadolol

Nadolol EP Impurity G;

Dideoxy Nadolol (USP)

026

5-(2-bromoethyl)-2,3-dihydro-1-

benzofuran

C10H11BrO

MWt: 227.10

127264-14-6

Darifenacin related compound

027 2,2-diphenyl-2-[(3S)-pyrrolidin-3-

yl]acetonitrile;hydrobromide

C18H19BrN2

MWt: 343.26

194602-27-2

Darifenacin related compound

Page 5: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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028 (2R,3R)-2,3-dihydroxybutanedioic

acid;2,2-diphenyl-2-[(3S)-pyrrolidin-3-

yl]acetamide C22H26N2O7

MWt: 430.45

134002-26-9

Darifenacin related compound

029 (S)-2-{1-[3-(2-Bromoethyl)-4-

hydroxyphenethyl]pyrrolidin-3-yl}-2,2-

diphenylacetamide

C28H31BrN2O2

MWt: 507.46

NA

Darifenacin related compound

030 (S)-2-[1-[2-(2,3-Dihydrobenzfuran-5-

yl)ethyl]-3-pyrrolidinyl]-2,2-diphenyl-N-

[2-(2,3-dihydrobenzfuran-5-

yl)ethyl]acetamide hydrobromide

C38H41BrN2O3

M.Wt: 653.65

:

NA

Darifenacin Dimer-2

impurity

Darifenacin related compound

031 (S)3-(2-Amino-2-oxo-1,1-diphenylethyl)-

1,1-bis(2-(2,3-dihydrobenzofuran-5-

yl)ethyl)pyrrolidin-1-ium bromide

C38H41BrN2O3

M Wt: 653.65

NA

Darifenacin Bis quaternary

ammonium salt

Darifenacin related compound

032 Methyl 7-[(1R,2R,3R)-3-hydroxy-2-[(E)-4-

hydroxy-4-methyloct-1-enyl]-5-

oxocyclopentyl]heptanoate C22H38O5

Molecular Weight: 382.53

59122-46-2

Misoprostol

Page 6: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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033 Methyl 7-[(1R,2S)-2-[(E)-4-hydroxy-4-

methyloct-1-enyl]-5-oxocyclopent-3-en-1-

yl]heptanoate C22H36O4

M.Wt.: 364.52

58682-86-3

Type-A misoprostol

Misoprostol EP Impurity C

034 Methyl 7-[2-[(E)-4-hydroxy-4-methyloct-

1-enyl]-5-oxocyclopenten-1-yl]heptanoate

C22H36O4

M.Wt.: 364.52

1331639-92-9

Type-B misoprostol

Misoprostol EP Impurity D

035 Methyl (1S*,2R*,3R*)-3-hydroxy-2-[(E)-

4-hydroxy-4-methyl-1-octenyl]-5-

oxocyclopentaneheptanoate

C22H38O5

M.Wt.: 382.53

NA

8-epi misoprostol

Misoprostol EP Impurity A

036

Methyl (1S*,2R*,3S*)-3-hydroxy-2-[(E)-

4-hydroxy-4-methyl-1-octenyl]-5-

oxocyclopentaneheptanoate

C22H38O5

M.Wt.: 382.53

NA

12-epi misoprostol

Misoprostol EP Impurity B

037

Methyl 7-[(1R,2R,3S)-3-hydroxy-2-[(E)-4-

hydroxy-4-methyloct-1-enyl]-5-

oxocyclopentyl]heptanoate

C22H38O5

M.Wt.: 382.53

58717-36-5

11-epi misoprostol

Misoprostol EP Impurity E

038 Methyl 7-(3-hydroxy-5-oxocyclopenten-1-

yl)heptanoate C13H20O4

M.Wt: 240.30

40098-26-8

Norprostol

Misoprostol EP impurity F

Page 7: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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039 (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-

[(E)-(3R)-3-hydroxy-3-methyloct-1-

enyl]cyclopentyl]-5-heptenoic acid.

C21H36O5

M.Wt.: 368.51

NA

15-epi Carboprost

040 (E)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-

[(E)-(3S)-3-hydroxy-3-methyloct-1-

enyl]cyclopentyl]-5-heptenoic acid

C21H36O5

M.Wt,: 368.51

NA

trans-Carboprost

042

2-amino-2-(hydroxymethyl)propane-1,3-

diol

C4H11NO3

M.Wt.: 121.14

77-86-1

Tromethamine

043 (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-

[(E,3S)-3-hydroxy-5-phenylpent-1-

enyl]cyclopentyl]hept-5-enoic acid

C23H32O5

Exact Mass: 388.22

38344-08-0

Bimatoprost S-Acid

044 (5Z)-7-((1R,2R,3R,5R)-3,5-dihydroxy-2-

((S,E)-3-hydroxy-5-phenylpent-1-

enyl)cyclopentyl)hept-5-enoic acid

C23H32O5

Exact Mass: 388.22

NA

Bimatoprost R-Acid

Page 8: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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045

15-Keto Bimatoprost

C25H35NO4

Exact Mass: 413.26

NA

15-Keto Bimatoprost

046 (5Z)-methyl 7-((1R,2R,3R,5S)-3,5-

dihydroxy-2-((S,E)-3-hydroxy-5-

phenylpent-1-enyl)cyclopentyl)hept-5-

enoate

C24H34O5

Exact Mass: 402.24

NA

Bimatoprost Acid

Methyl Ester

47 propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-

dihydroxy-2-[(E,3R)-3-hydroxy-5-

phenylpent-1-enyl]cyclopentyl]hept-5-

enoate

C26H38O5

M.Wt.: 430.58

130273-87-9

Bimatoprost isopropyl ester

48 (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-

[(E,3R)-3-hydroxy-5-phenylpent-1-

enyl]cyclopentyl]-N-ethylhept-5-enamide

C25H37NO4

M.Wt.: 415.57

1163135-92-9

15-epi Bimatoprost ((15R)-

Bimatoprost)

49 ((E)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-

[(E,3S)-3-hydroxy-5-phenylpent-1-

enyl]cyclopentyl]-N-ethylhept-5-enamide

C25H37NO4

M.Wt.: 415.57

1163135-95-2

5.6 TRANS- BIMATOPROST

IMPURITY

050

(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-

[(E,3R)-3-hydroxy-4-[3-

(trifluoromethyl)phenoxy]but-1-

enyl]cyclopentyl]hept-5-enoic acid

C23H29F3O6

54276-17-4

Travoprost Acid

Page 9: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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Exact Mass: 458.19

051

propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-

dihydroxy-2-[(E)-3-oxo-4-[3-

(trifluoromethyl)phenoxy]but-1-

enyl]cyclopentyl]hept-5-enoate

C26H33F3O6

Exact Mass: 498.53

404830-45-1

15-Keto Travoprost

052 2-(11-(3-(Dimethylamino)propylidene)-

6,11-dihydrodibenzo[b,e]oxepin-2-yl)-N-

methoxy-N-methylacetamide

C23H28N2O3

M. Wt.: 380.48

NA

Olopatadine impurity

053 2-[(11Z)-11-[3-

(dimethylamino)propylidene]-6H-

benzo[c][1]benzoxepin-2-yl]acetaldehyde

C21H24ClNO2

M.Wt.: 357.87

1376615-97-2

Olopatadine Carbaldehyde.

Hydrochloride

054 5-(Diphenylphosphoryl)pentanoic acid

C17H19O3P

M.Wt.: 302.30

71140-70-0

Latanoprost impurity

055 Methyl 5-(diphenylphosphoryl)pentanoate

C18H21O3P

M.Wt.: 316.33

146964-27-4

Latanoprost impurity

056 (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-

[(3R)-3-hydroxy-5-

phenylpentyl]cyclopentyl]hept-5-enoic

acid

C23H34O5

Exact Mass: 390.24

41639-83-2

Latanoprost Acid

Page 10: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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057

(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-

oxo-5-phenylpentyl)cyclopentyl]hept-5-

enoic acid C23H32O5

M.W. 388.51

369585-22-8

15-Keto Latanoprost Acid

058 5,6-trans-Latanoprost

C26H40O5

Exact Mass: 432.29

NA

5,6-trans-Latanoprost

059 propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-

dihydroxy-2-[(3S)-3-hydroxy-5-

phenylpentyl]cyclopentyl]hept-5-enoate

C26H40O5

Exact Mass: 432.29

145773-22-4

15(S)-Latanoprost

060

4,6-dichloro-2-methylsulfanylpyrimidine

C5H4Cl2N2S

M.Wt.: 195.07

6299-25-8

Alogliptin impurity

061

4,6-dichloro-2-methylsulfonylpyrimidine

C5H4Cl2N2O2S

M.Wt.: 227.07

4489-34-3

Alogliptin impurity

062 2-((4,6-Dichloropyrimidin-2-

yloxy)methyl)benzonitrile)

C12H7Cl2N3O

M.Wt.: 280.11

NA

Alogliptin impurity

Page 11: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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063 2-((4,6-Dimethoxypyrimidin-2-

yloxy)methyl)benzonitrile

C14H13N3O3

M.Wt.: 271.27

NA

Alogliptin impurity

064 2,2'-(((6-Chloropyrimidine-2,4-

diyl)bis(oxy))bis(methylene))dibenzonitrile

C20H13ClN4O2

M.Wt.: 376.80

NA

Alogliptin impurity

065 (6-Chloro-2-(methylthio)pyrimidin-4-ol)

C5H5ClN2OS

M.Wt.: 176.62

NA

Alogliptin impurity

066 2-[[5-methoxy-1-[4-

(trifluoromethyl)phenyl]pentylidene]amino

]oxyethanamine

C15H21F3N2O2

M.Wt.: 318.33

917096-37-8

Fluvoxamine impurity B

067

1-azabicyclo[2.2.2]octan-3-yl 2-hydroxy-

2,2-diphenylacetate

C21H23NO3

Exact Mass: 337.17

6581-06-2

Oxybutynin impurity

Page 12: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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068

methyl 2-hydroxy-2,2-diphenylacetate

C15H14O3

Exact Mass: 242.09

76-89-1

Oxybutynin impurity

069

4-(diethylamino)but-2-ynyl 2-hydroxy-

2,2-diphenylacetate

C22H25NO3

Exact Mass: 351.18

14943-53-4

Oxybutynin EP Impurity B

070

4-[ethyl(methyl)amino]but-2-ynyl 2-

cyclohexyl-2-hydroxy-2-phenylacetate

C22H31NO3

Exact Mass: 357.23

1199574-70-3

Oxybutynin Impurity C

071 Methyl 2-cyclohexyl-2-hydroxy-2-

phenylacetate

C15H20O3

Exact Mass: 248.14

10399-13-0

Oxybutynin Impurity 1

(Cyclohexyl Mandelic Acid Methyl

Ester)

Page 13: LABORATORIES PVT LTD › docs › sumalabs_impurities.pdf · Carvedilol USP-A Carvedilol EP Impurity A 006 1-(9H-carbazol-4-yloxy)-3-[[3-(9H-carbazol-4-yloxy)-2-hydroxypropyl]-[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

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072

Ethyl 2-cyclohexyl-2-hydroxy-2-

phenylacetate C16H22O3

Exact Mass: 262.16

31197-69-0

Oxybutynin Impurity 2

(Phenylcyclohexylglycolic Acid

Ethyl Ester)

073

2-(1-cyanocyclohexyl)acetic acid

C9H13NO2

Exact Mass: 167.09

133481-09-1

Gabapentin impurity B

074

2-[1-[(3-oxo-2-azaspiro[4.5]decan-2-

yl)methyl]cyclohexyl]acetic acid

C18H29NO3

Exact Mass: 307.21

1076198-17-8

Gabapentin impurity D

075

2-(cyclohexanecarbonyloxy)acetic acid

C9H13NO2

Exact Mass: 167.09

667465-00-1

Gabapentin impurity E

076 2-(1-(2-aminoethyl)cyclohexyl)acetic acid

C10H19NO2

Exact Mass: 185.14

1500558-49-5

Gabapentin impurity G

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077

calcium;(3S,5R)-7-[2-(4-fluorophenyl)-3-

phenyl-4-(phenylcarbamoyl)-5-propan-2-

ylpyrrol-1-yl]-3,5-dihydroxyheptanoate

C33H35FN2O5

Exact Mass 557.63

887196-25-0

Atorvastatin related compound

B

078

calcium;(3R,5R)-7-[2,3-bis(4-

fluorophenyl)-4-(phenylcarbamoyl)-5-

propan-2-ylpyrrol-1-yl]-3,5-

dihydroxyheptanoate

C33H33F2N2NaO5

Exact Mass: 597.61

693793-53-2

Atorvastatin Related compound

C.

079

4-[7-(4-fluorophenyl)-7-hydroxy-7a-

phenyl-1a-(phenylcarbamoyl)-1b-propan-

2-yl-4,5-dihydro-3H-

oxireno[1,2]pyrrolo[4,5-b][1,3]oxazin-3-

yl]-3-hydroxybutanoic acid;

C33H34FN2NaO7

Exact Mass: 612.22

1316291-19-6

Atorvastatin FXA Impurity

(Atorvastation epoxy

pyrrolooxazin 6-hydroxy analog

080 sodium;4-[1b-(4-fluorophenyl)-7-hydroxy-

1a-phenyl-7a-(phenylcarbamoyl)-7-

propan-2-yl-4,5-dihydro-3H-

oxireno[1,2]pyrrolo[3,5-b][1,3]oxazin-3-

yl]-3-hydroxybutanoate

C33H34FN2NaO7

Exact Mass: 612.22

1315629-79-8

NH

O

ON

OH

F

O

OH

ONa

O

Atorvastatin FX1 Impurity

(Atorvastation epoxy

pyrrolooxazin 7-hydroxy analog

081 5-(4-fluorophenyl)-1-[2-[(2R,4R)-4-

hydroxy-6-oxooxan-2-yl]ethyl]-N,4-

diphenyl-2-propan-2-ylpyrrole-3-

carboxamide

C33H33FN2O4

Exact Mass: 540.24

125995-03-1

Atorvastatin related compound H

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082 4-(4-fluorophenyl)-2,4-dihydroxy-N,5-

diphenyl-2-propan-2-yl-3,6-

dioxabicyclo[3.1.0]hexane-1-carboxamide

C26H24FNO5

Exact Mass: 449.16

873950-19-7

Atorvastatin Epoxy

Tetrahydrofuran Analog

083 3-(4-fluorobenzoyl)-2-(2-methylpropyl)-

N,3-diphenyloxirane-2-carboxamide

C26H24FNO3

Exact Mass: 417.17

1246818-88-1

Atorvastatin Oxirane Impurity

084 Tert-butyl (3R,5R)-7-[2-(4-fluorophenyl)-

3-phenyl-4-(phenylcarbamoyl)-5-propan-

2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate

C37H43FN2O5

Exact Mass: 614.32

134395-00-9

Atorvastatin tert-Butyl Ester

085

Bumetanide intermediate

C13H12N2O5S

Exact Mass: 308.05

NA

Bumetanide intermediate

086

3-(2-ethylhexylamino)-4-phenoxy-5-

sulfamoylbenzoic acid

C21H28N2O5S

Exact Mass: 420.17

153012-65-8

Bumetanide impurity

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087

(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-

prop-1-en-2-yl-2-propyl-3-[[4-[2-(2H-

tetrazol-5-

yl)phenyl]phenyl]methyl]imidazole-4-

carboxylate C29H28N6O5

Exact mass: 540.21

879562-26-2 N

NNH

NN

NO

O

O

O

O

Olmesartan -EP impurity C

088 (2S)-2-(5-chloro-6-methoxynaphthalen-2-

yl)propanoic acid

C14H13ClO3

Exact Mass: 264.06

89617-86-7 O

Cl

(S)OH

O

Naproxen-EP-IMP-B

089

(2S)-2-(5-iodo-6-methoxynaphthalen-2-

yl)propanoic acid

C14H13IO3

Exact Mass: 355.99

116883-62-6

O

I

(S)OH

O

Naproxen-EP-IMP-D

090 (S)-2-(1-bromo-2-methoxynaphthalen-6-

yl)propanoic acid

C14H13BrO3

Exact Mass: 308

84236-26-0 O

Br

(S)OH

O

Naproxen-EP-IMP-C

091

(2R)-2-[[4-[2-(2-amino-4-oxo-1,7-

dihydropyrrolo[2,3-d]pyrimidin-5-

yl)ethyl]benzoyl]amino]pentanedioic

acid;sodium

C20H21N5O6

Exact Mass: 427.15

937370-10-0

HN

N NH

O

H2N

NH

O

(R)

O

OH

O

OH

(D-Pemetrexed Disodium, EP

Imp. E

092 5-(Propylsulphanyl)-1H-benzimidazol-2-

amine

C10H13N3S

Exact Mass: 207.08

80983-36-4 N

HN

S

NH2

Albendazole EP Impurity A

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093 Methyl N-[5-propylsulfinyl)-1H-

benzo[d]imidazol-2-ylcarbamate

C12H15N3O3S

Exact Mass: 281.08

54029-12-8 N

HN

S

NH

O

O

O

Albendazole EP Impurity B

094 Methyl N-(5-propylsulfonyl)-1H-

benzo[d]imidazol-2-ylcarbamate

C12H15N3O4S

Exact Mass: 297.08

75184-71-3 N

HN

S

NH

O

O

O

O

Albendazole EP Impurity C

095

2-Amino-1H-benzimidazole-5-yl)propyl-

sulfanedione

C10H13N3O2S

Exact Mass: 239.07

80983-34-2 N

HN

S

NH2

O

O

Albendazole EP Impurity D

096

Methyl N(1H-benzo[d]imidazol-2-

yl)carbamate

C9H9N3O2

Exact Mass: 191.07

10605-21-7 N

HN

NH

O

O

Albendazole EP Impurity E

097

Methyl –N-5-(methylsulfanyl)-1H-

benzo[d]imidazol-2-ylcarbamate

C10H11N3O2S

Exact Mass: 237.06

80983-45-5 N

HN

S

NH

O

O

Albendazole EP Impurity F

(Under development)

098

Methyl N 5-chloro-1H-benzo[d]imidazol-2-

ylcarbamate

C9H8ClN3O2

Exact Mass: 225.03

N

HN

Cl

NH

O

O

Albendazole EP Impurity G

099 Methyl N 5-(2-methyl-4-oxopentan-2-

yl)sulfanyl-1H-benzo[d]imidazol-2-

ylcarbamate

C15H19N3O3S

Exact Mass: 321.11

NA

S

O

N

HN

NH

O

O

Albendazole EP Impurity H

(Under development)

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100 Methy N (5-propoxy-1H-benzo[d]imidazol-

2-ylcarbamate

C12H15N3O3

Exact Mass: 249.11

20559-55-1 N

HN

O

NH

O

O

Albendazole EP Impurity I

101

Methyl N 4,6-dichloro-1H-

benzo[d]imidazol-2-ylcarbamate

C9H7Cl2N3O2

Exact Mass: 258.99

946498-41-5 N

HN

NH

O

O

Cl

Cl

Albendazole EP Impurity J

102 Methyl N 5-(butyl sulfanyl)-1H-

benzo[d]imidazol-2-ylcarbamate

C13H17N3O2S

Exact Mass: 279.1

N

HN

S

NH

O

O

Albendazole EP Impurity K

103 Methyl N [5-(propane-2-yl)sulfanyl]-1H-

benzimidazol-2-yl] carbamate

C12H15N3O2S

Exact Mass: 265.09

108579-67-5 N

HN

S

NH

O

O

Albendazole EP Impurity L

(Under development)

104

Gabapentine in-house impurity

C13H21NO2

Exact Mass: 223.16

---

NO

O

Gabapentine inhouse impurity

105 Diclofenac impurity-A

C14H9Cl2NO

Exact Mass: 277.01

15362-40-0

Cl Cl

NO

Diclofenac impurity-A

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106

Olopatadine amide impurity (Z-isomer)

O

N

O

N

C23H28N2O2Exact Mass: 364.22

Olopatadine amide impurity (Z-

isomer)

107

Olopatadine isopropyl ester impurity (Z-

isomer)

O

N

O

O

C23H28N2O2Exact Mass: 364.22

Olopatadine isopropyl ester

impurity (Z-isomer)

108

Oxybutynin-EP-Impurity-C

1199574-70-3

HOO

ON

C21H29NO3Exact Mass: 343.21

Oxybutynin-EP-Impurity-C

109

Oxybutynin-EP-Impurity-E

1215677-72-7 HOO

ON

C23H33NO3Exact Mass: 371.25

Oxybutynin-EP-Impurity-E

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110

Escitolopram EP impurity-I

NOH

F

N

C20H21FN2OExact Mass: 324.16

Escitolopram EP impurity-I

111

N-methoxy-N-

methylcyclohexanecarboxamide

80783-98-8 N

O

O

C9H17NO2Exact Mass: 171.13

-----------

112

1-cyclohexylprop-2-en-1-one

------

O

C9H14OExact Mass: 138.1

----------------

113

Formetrol Impurity A

150513-24-9 NH2

HO

HN

OH

O

C18H24N2O3Exact Mass: 316.18

Formetrol Impurity A

114

Formetrol Impurity B

1224588-66-2

OH

NHCHO

HO

HN

O

C18H22N2O4Exact Mass: 330.16

Formetrol Impurity B

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115

15-S-Travoprost 1420791-14-5

O

OO

F

F

F

HO

OHHO

1420791-14-5

116

Carvedilol Propane diol

123119-89-1

NH

OOH

OH

Carvedilol Propane diol

117 Sorafenib impurity A

(IP2014)

284462-37-9 NH2

O

N

NH

O

C13H13N3O2Exact Mass: 243.1

Sorafenib impurity A

(IP2014)

118 Sorafenib impurity B

(IP2014)

NH

NH

OClCl

CF3F3C

1,3-bis(4-chloro-3-(trifluoromethyl)phenyl)urea

C15H8Cl2F6N2OExact Mass: 415.99

Sorafenib impurity B

(IP2014)

119

Sorafenib impurity C

(IP2014)

1431697-81-2

F3C

Cl HN

HN

O O

N

O

NH

C21H16ClF3N4O3Exact Mass: 464.09

Sorafenib impurity C

(IP2014)

120

Sorafenib related compound-15

284670-98-0

NH

NH

OO

N

NH

O

O

N

NH

O

C27H24N6O5Exact Mass: 512.18

Sorafenib related

compound-15

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121

Sorefenib impurity

( Under development)

2204442-52-2

NH

NH

OO

N

NH

O

O

N

O

O

C27H23N5O6Exact Mass: 513.16

Sorefenib impurity

( Under development)

122 Sorafenib Phenyl carbamate NH

OCl

F3C O

phenyl 4-chloro-3-(trifluoromethyl)phenylcarbamate

C14H9ClF3NO2Exact Mass: 315.03

Sorafenib Phenyl carbamate

123

Diclofenac isopropyl ester

66370-79-4

Cl

Cl

NH

O

O

C17H17Cl2NO2Exact Mass: 337.06

Diclofenac isopropyl ester

124 Tropicamide related compound A 33403-97-3 N

NH

C8H12N2Exact Mass: 136.1

Tropicamide related compound A

125 Tropicamide related compound D 103-82-2 OH

O

Tropicamide related compound D

126

Propofol EP impurity B

74926-89-9

Propofol EP impurity B

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127

Propofol EP impurity D

35946-91-9

Propofol EP impurity D

128

Propofol EP impurity E

2416-95-7

Propofol EP impurity E

129

Propofol EP impurity F

618-45-1

Propofol EP impurity F

130

Propofol EP impurity G

141214-18-8

Propofol EP impurity G

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131

Propofol EP impurity J

1988-11-0

Propofol EP impurity J

132

Propofol EP impurity K

14366-59-7

Propofol EP impurity K

133

Propofol EP impurity L

201166-22-5

Propofol EP impurity L

134

Propofol EP impurity O

74663-48-2

Propofol EP impurity O

135

Propofol EP impurity P

2095678-97-8

Propofol EP impurity P

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136

Propofol EP impurity N

13423-73-9

Propofol EP impurity N

137

1-{1-[4, 4-Bis (4-Fluorophenyl) but-3-en-

1-yl] piperidin-4-yl} benzimidazolin-2-one

NA

Pimozide olefin impurity

138

Diisopropylhomoveratrylcyanide

51698-54-5

Verapamil impurity

139

2-(3, 4—Dimethoxy-phenyl) 3-methyl-1-

but-2enenitrile

20850-47-9

Verapamil impurity

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140

2-(3,4-dimethoxyphenyl)-3-

methylbutanenitrile

Verapamil impurity

20850-49-1

Verapamil impurity

141

4-(3-nitrophenyl)morpholin-3-one

845729-43-3

4-(3-nitrophenyl)morpholin-3-

one

142 4-(3,5-dinitrophenyl) morpholin-3-one 2138262-09-4

4-(3,5-dinitrophenyl)

morpholin-3-one

143 N-(pyridin-2-ylmethyl)-2, 5-bis (2, 2, 2-

trifluoroethoxy) benzamide

57415-36-8

N-(pyridin-2-ylmethyl)-2, 5-bis (2,

2, 2-trifluoroethoxy) benzamide

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144

4-[4-[[[[4-Chloro-3-(trifluoromethyl)

phenyl] amino] carbonyl] amino] phenoxy]-

N-methyl-2- pyridinecarboxamide 1-Oxide

583840-03-3

Sorafenib N-Oxide

145

Phenyl (1H-pyrrol-1-yl) methanone

5145-65-3

N-benzoyl pyrrole

146

4-((7-chloroquinolin-4-yl)amino)-N-ethyl-N-

(2-hydroxyethyl)pentan-1-amine oxide

1449223-88-4

Hydroxy chloroquine Imp A

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147

Sodium 2-((4-((7-chloroquinolin-4-

yl)amino)pentyl)(ethyl)amino)ethyl sulfate

103152-84-7

( Free Acid)

Hydroxy chloroquine Imp B

148

2-((4-((7-chloroquinolin-4-

yl)amino)pentyl)amino)ethan-1-ol

4298-15-1

Hydroxy chloroquine Imp C

149

N4-(7-chloroquinolin-4-yl)-N1-

ethylpentane-1,4-diamine

1476-52-4

Hydroxy chloroquine Imp D

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150

4-((7-chloroquinolin-4-yl)amino)pentan-1-ol

10500-64-8

Hydroxy chloroquine Imp E

151

7-chloro-4-(2-methylpyrrolidin-1-

yl)quinoline

6281-58-9

Hydroxy chloroquine Imp F

152

4,7-dichloroquinoline

86-98-6

Hydroxy chloroquine Imp G

153

2-[[4-[(7-Chloro-4-quinolinyl) amino]

pentyl] ethylamino] ethanol 1-Acetate

47493-14-1

Hydroxy chloroquine O-Acetyl

impurity