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  • Divalproex Tablets 500 MG Dissolution Data

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    This document summarizes dissolution test results for 3 validation batches of 500 mg Divalproex Sodium ER Tablets at different time points. The results are reported as a percentage of drug released and meet the release specification of 15-35% at 2 hours, 40-65% at 6 hours, 65-90% at 12 hours, and not less than 80% at 24 hours. All 30 individual results from the 3 validation batches were within the release specifications at each time point tested.

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    This document summarizes dissolution test results for 3 validation batches of 500 mg Divalproex Sodium ER Tablets at different time points. The results are reported as a percentage of drug released and meet the release specification of 15-35% at 2 hours, 40-65% at 6 hours, 65-90% at 12 hours, and not less than 80% at 24 hours. All 30 individual results from the 3 validation batches were within the release specifications at each time point tested.

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    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
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    5 views1 page

    Divalproex Tablets 500 MG Dissolution Data

    Uploaded by

    syedburhanuddinmoin
    This document summarizes dissolution test results for 3 validation batches of 500 mg Divalproex Sodium ER Tablets at different time points. The results are reported as a percentage of drug released and meet the release specification of 15-35% at 2 hours, 40-65% at 6 hours, 65-90% at 12 hours, and not less than 80% at 24 hours. All 30 individual results from the 3 validation batches were within the release specifications at each time point tested.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xlsx, pdf, or txt
    of 1

    Divalproex Sodium ER Tablets USP 500 mg

    Dissolution medium: pH 6.8 phosphate Buffer with 2% SLS


    Release Specification (L1 criteria): 2hrs: 15 to 35%, 6hrs: 40-65%, 12hrs: 65-90%, 24hrs: NLT 80%
    1st Validation batch 2nd Validation batch 3rd Validation batch
    Time point B. No. DSB19001 DSB19001A DSB19001B DSB20001 DSB20001A DSB20001B DSB20002 DSB20002A DSB20002B
    Lot1 (L3) Lot2 (L3) (100's count) (500's count) Lot1 (L2) Lot2 (L1) (100's count) (500's count) Lot1 (L2) Lot2 (L2) (100's count) (500's count)
    63% (58-70) 65% (56-72) 69% (63-73) 67% (62-71) 69% (62-77) 66% (65-68) 68% (64-73) 71% (63-79) 65% (58-70) 65% (61-74) 66% (61-70) 67% (59-72)
    (67,62,60,63,61,67, (67,62,56,62,67,61, (71,73,65,71,71,67, (71,69,69,68,67,66, (67,62,72,69,67,69, (66,65,66,67,65,68) (68,68,73,67,69,66, (79,70,71,75,70,73, (60,67,68,62,67,67, (62,62,61,65,62,62, (69,68,68,67,65,65, (62,64,70,70,69,70,
    12th Hour 64,61,67,67,70,64, 58,66,58,62,58,62, 72,67,65,67,63,72) 69,62,63,66,71,67) 69,66,66,71,72,77) 64,71,68,69,66,65) 66,63,63,68,77,74) 62,69,70,63,69,58) 74,62,70,66,62,66) 67,61,61,65,70,66) 59,59,69,70,72,67)
    58,58,63,63,64,62, 71,65,70,59,68,68,
    59,59,65,60,62,65) 70,69,68,69,72,62)

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