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  • Code 290-21941

    Limulus J Test Wako 50

  • $

    $ m

    m6!sAwWk3nYV# fd86!m 3

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    m j nA+}Z4$

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    #g

  • $

    # 3 + V 3 GiC)Ej Ve

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    KiCRg3 VeIJiP-oi+}Z4$ g

    3 V^#mm pH K m J*nY-, jn i m ^\~:t}^n f

    m pH 3 m j X, KA+}X$

  • K jib^ j# m K V^

  • j log JPSE conc. EU/ml g log Tg min. m log Tg min A log JPSEconc. EU/ml B A, B ; 3 j)be "# gV}X$Rm #

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    Tg mean 3 "}X$Rm # V^ mE‘ K JPSE mTgm jnC*iP-oi+}Z

    4$

    m m

    m m

  • CSE m EU m

    Table 3 JPSE m EU/ml g Tg min.

    JPSE (EU/ml ) Tg (min.)

    0.0625 50.8 49.2 0.0125 42.8 42.2 0.025 35.0 34.8 0.5 30.0 29.8 1.0 24.8 24.4 2.0 21.0 21.4

    log (Tg (min.) ) 0.251 log (JPSE conc. (EU/ml ) ) 1.397 r 0.9989

    Table 4 CSE m ng/ml g Tg mean min.

    CSE (ng/ml ) Tg mean (min)

    vial 1 vial 2 vial 3 vial 4

    0.00625 49.5 50.1 57.8 51.3 0.0125 40.2 42.2 43.1 42.0 0.025 34.8 35.4 36.3 36.7 0.05 29.9 31.2 31.2 30.0 0.1 24.6 24.2 24.8 24.5

    Table 5 CSE m EU

    CSE d86!m Tg EU EU (ng/ml ) (min) (EU/ml ) (EU/ng)

    0.00625 52.1 0.0532 8.51 0.0125 41.9 0.1268 10.14 0.025 35.8 0.2375 9.50 0.05 30.6 0.4439 8.88 0.1 24.5 1.0772 10.77

    EU 9.56 (EU/ng)

    500 (ng/vial) 9.56 (EU/ng) 4780 (EU/vial) beRm fn CSE m n 4800 (EU/vial) gi+}X"

  • $Bang, F. B. : Bull. Johns Hopkins Hosp., 98, 325 (1956).

    $Levin, J. and Bang, F. B. : Bull. Johns Hopkins Hosp., 115,

    265 (1964).

    $Westphal, O., L ›uderitz, O., Eichenberger, E. and Keiderling,

    W. : Z. Naturforsch., 7b, 536 (1952).

    $Akama, K., Kuratsuka, K., and Homma, R., Kanoh, S.,

    Niwa, M., Iwanaga, S. and Nakahara, C. : Bacterial En-

    dotoxin, eds. Homma, J.Y. et al., p395, Verlag Chemie (1984).

    $ # # # #

    #38 (6), 781 (1983).

    $The United States Parmacopeia 22th, The National Formulary

    17th, p1493, U.S. Pharmacoperial Conversion Inc (1990).

    $Oishi, H., Takaoka, A., Hatayama, Y., Matsuo, T. and

    Sakata, Y. : J. Parenter. Sci. Technol., 39 (5), 194 (1985).

    STUVWXYZ[\

    TEL

    TEL

    Charles River Endosafe Div. of Charles River Laboratories, Inc. 1023 Wappo Rd., Suite 43-B Charleston, SC 29407 Telephone : 843 766-7575

    0606K02

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