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Excipients microbial limits

The tests for microbial limits and recommendations for microbial quality criteria of raw materials, excipients, drug substances, and pharmaceutical products have been established in pharmacopoeial compendia for over 30 years. These tests are listed in the USP 24 Chapter (61) Microbial Limits Tests and in the Ph. Eur. 3rd ed.. Biological Tests 2.6.12 and 2.6.13, Microbial Contamination of Products Not Required to Comply with the Test for Sterility (total viable count, tests for specified microorganisms) and the JP XIII 30 Microbial Limit Test. [Pg.222]

Testing of primary packaging materials, raw materials (excipients, active substances, water) and products according to internal or official methods and specifications. Microbial limits of pharmaceutical preparations are given in relevant monographs of the European Pharmacopoeia. Section 19.6 provides a deeper insight on the European test methods of pharmaceutical preparations and acceptance criteria. [Pg.396]

See other pages where Excipients microbial limits is mentioned: [Pg.8]    [Pg.178]    [Pg.824]    [Pg.84]    [Pg.507]    [Pg.8]    [Pg.178]    [Pg.282]    [Pg.787]   
See also in sourсe #XX -- [ Pg.84 ]



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