Qualification of Dissolution Testers USP Performance Verification Test (PVT)

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  • เผยแพร่เมื่อ 28 เม.ย. 2021
  • This webinar was aired live on April 29, 2021. Speaker is Alex Fiechter, Senior SCD Manager EMEA. Alex gives an introduction to USP 711 Dissolution-Apparatus 1 and 2. This is followed by an excursion to possible sources of variability during testing. His presentation includes also information how to qualify dissolution testing devices. He concludes his talk by pointing out the benefits of performance verification testing, also known as PVT.
    Please send an email to emea@usp.org for any questions.
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ความคิดเห็น • 8

  • @nn-yl6bd
    @nn-yl6bd 2 ปีที่แล้ว +1

    I do thank you for sharing this🌷

  • @matchmedicines8209
    @matchmedicines8209 ปีที่แล้ว

    thanks for the perfect explanation🙏🏻
    I have a question, is it necessary to do the disintegration test before the dissolution test?

  • @shifaeqalb6661
    @shifaeqalb6661 ปีที่แล้ว

    is there active limit mention in guideline ?
    how much active atleast should be present in tablet for dissolution test requirement?
    if tablet contain 5 or 25 mg active ingredient should we perform dissolution test on it or not require?

  • @ds3718
    @ds3718 10 หลายเดือนก่อน

    Please share updated dissolution calibration procedure..

  • @aniketsingh1371
    @aniketsingh1371 2 ปีที่แล้ว +1

    Sir, can you please tell me about the use of chlorpheniramine tablets in USP apparatus type 3? is it removed from USP as I could not find any source of access. pp

    • @takeshiinoue4105
      @takeshiinoue4105 2 ปีที่แล้ว

      Chlorpheniramine Maleate ER Tablets RS was announced to be discontinued on December 20, 2012. The 30 dips per minute test is no longer required in the Performance Verification Test for USP Instrument 3.

    • @takeshiinoue4105
      @takeshiinoue4105 2 ปีที่แล้ว

      Effective February 1, 2012, USP has removed the requirement for Apparatus 3 Performance Verification Test Apparatus Suitability section of General Chapter Dissolution.
      The change was necessary because the supply of current lot G1J218 has been depleted and no suitable replacement has been found.

  • @pmman4232
    @pmman4232 ปีที่แล้ว

    Is this channel legit?