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  • PK Simvastatin Tablet 14/10/19

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    This document summarizes the results of simvastatin tablet testing conducted by two analysts on two batches. The testing measured parameters like retention time, tailing, column type, mobile phase and found the content of simvastatin to be between 90-110% as required. The average content for different analysts and batches ranged from 10.30 to 10.48 mg with a RSD of 0.11% to 0.14% meeting the acceptance criteria of ≤0.67 times the Horwitz coefficient.

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    This document summarizes the results of simvastatin tablet testing conducted by two analysts on two batches. The testing measured parameters like retention time, tailing, column type, mobile phase and found the content of simvastatin to be between 90-110% as required. The average content for different analysts and batches ranged from 10.30 to 10.48 mg with a RSD of 0.11% to 0.14% meeting the acceptance criteria of ≤0.67 times the Horwitz coefficient.

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    8 views4 pages

    PK Simvastatin Tablet 14/10/19

    Uploaded by

    Ninda
    This document summarizes the results of simvastatin tablet testing conducted by two analysts on two batches. The testing measured parameters like retention time, tailing, column type, mobile phase and found the content of simvastatin to be between 90-110% as required. The average content for different analysts and batches ranged from 10.30 to 10.48 mg with a RSD of 0.11% to 0.14% meeting the acceptance criteria of ≤0.67 times the Horwitz coefficient.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
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    of 4

    PK SIMVASTATIN TABLET 14/10/19

    Syarat 90.0-110.0% RT ± 7.3 mnt; flow 1.5, tailing 0.98


    Kolom Xbridge ODS Pelarut PENGENCER
    250 mm x 4.6 mm; 10 µm Fase Gerak DAPAR-CAN (35-65)

    Penguji 1 Baku 1: 16.190-11.215

    W+Z W Z AU AB BB KB SP Fu Fb BR mg kadar

    10.0 2081782 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.334


    10.0 2078187 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.316
    10.0 2082150 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.335
    Rata 10.33
    Br C: KE/Br SD 0.01
    #DIV/0! RSD 0.11
    Syarat ≤0,67 x Cv horw

    Penguji 1 Baku 2: 17.789-11.317

    W+Z W Z AU AB BB KB SP Fu Fb BR mg kadar

    10.0 2081782 2486374 6.172 0.9976 0.9997 1000 50 1.0 10.307


    10.0 2078187 2486374 6.172 0.9976 0.9997 1000 50 1.0 10.290
    10.0 2082150 2486374 6.172 0.9976 0.9997 1000 50 1.0 10.309
    Rata 10.30
    Br 0 C: KE/Br SD 0.01
    #DIV/0! RSD 0.11
    Syarat ≤0,67 x Cv horw
    Penguji 2 Baku 1:

    W+Z W Z AU AB BB KB SP Fu Fb BR mg kadar

    10.0 2091671 2002508 5.022 0.9976 0.9997 1000 50 1.0 10.463


    10.0 2095988 2002508 5.022 0.9976 0.9997 1000 50 1.0 10.484
    10.0 2096790 2002508 5.022 0.9976 0.9997 1000 50 1.0 10.489
    Rata 10.48
    Br 0 C: KE/Br SD 0.01
    #DIV/0! RSD 0.13
    Syarat ≤0,67 x Cv horw
    Penguji 2 Baku 2:

    W+Z W Z AU AB BB KB SP Fu Fb BR mg kadar

    10.0 2091671 2007202 5.015 0.9976 0.9997 1000 50 1.0 10.424


    10.0 2095988 2007202 5.015 0.9976 0.9997 1000 50 1.0 10.445
    10.0 2096790 2007202 5.015 0.9976 0.9997 1000 50 1.0 10.449
    Rata 10.44
    Br 0 C: KE/Br SD 0.01
    #DIV/0! RSD 0.13
    Syarat ≤0,67 x Cv horw

    Penguji 2, uks penguji 1 Baku 1: 16.190-11.215

    W+Z W Z AU AB BB KB SP Fu Fb BR mg kadar

    10.0 2091671 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.383


    10.0 2095988 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.404
    10.0 2096790 1999096 4.975 0.9976 0.9997 1000 50 1.0 10.408
    Rata 10.40
    Br C: KE/Br SD 0.01
    #DIV/0! RSD 0.13
    Syarat ≤0,67 x Cv horw
    λ 238 NM
    Max int
    Press 1605

    KE % kadar

    10 103.34
    10 103.16
    10 103.35
    103.28
    0.11
    rsd 0.11
    Cv horwitz #DIV/0!

    KE % kadar

    10 103.07
    10 102.90
    10 103.09
    103.02
    0.11
    rsd 0.11
    Cv horwitz #DIV/0!

    KE % kadar

    10 104.63
    10 104.84
    10 104.89
    104.79
    0.14
    rsd 0.13
    Cv horwitz #DIV/0!

    KE % kadar

    10 104.24
    10 104.45
    10 104.49
    104.40
    0.14
    rsd 0.13
    Cv horwitz #DIV/0!

    KE % kadar

    10 103.83
    10 104.04
    10 104.08
    103.98
    0.14
    rsd 0.13
    Cv horwitz #DIV/0!

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