Page 85 - Pharmaceutics IV (02-06-01305)
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Parenterals: Quality control testing

                     Sterility        Pyrogen
                     testing           testing

                     Leaker           Clarity
                     testing          testing

163

  Parenterals: Quality control testing

                          Sterility testing

  • The purpose of a sterility test is to determine the probable sterility of a
      specific batch.

  • The USP lists the procedural details for sterility testing and the
      sample sizes required.

  • It’s a destructive test (samples of the batch).

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Salma E. EL-Habashy
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