Pharmaceutical Finished Product Analysis

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  • October 22, 2023 at 9:33 am #4627
    aid
    Participant

      What are the fundamental tests for pharmaceutical finished product analysis?

      November 7, 2023 at 5:46 am #4687
      Pharma Digests
      Pharma Expert

        Fundamental tests for pharmaceutical finished products:
        – Identification
        – Assay
        – Dissolution
        – CU/WV
        – Impurity

        September 15, 2024 at 1:24 am #6265
        FRD
        Participant

          Is it mandatory to follow the monograph test method always?

          September 20, 2024 at 12:50 am #6292
          Pharma Digests
          Pharma Expert

            The monograph test method is generally recommended, but it is not mandatory. You can go with alternative method with following considerations:
            – Method is developed based on scientifically sound principles
            – Method is validated

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