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Sterility testing, parenteral dosage forms

Parenteral dosage forms require extensive testing of sterility and biological impurity contamination because of the high sensitivity of this administration route. These same sterility standards do not apply to solid and... [Pg.83]

All preservative systems for both parenteral and non-sterile dosage forms should meet the 3 log reduction at 14 days for bacteria., i.e., USP category I requirements. EP/BP Antimicrobial Effectiveness Testing would be run only if requested by the Marketing Group. [Pg.2787]

See other pages where Sterility testing, parenteral dosage forms is mentioned: [Pg.365]    [Pg.25]    [Pg.283]    [Pg.284]    [Pg.8]    [Pg.543]    [Pg.99]    [Pg.14]    [Pg.283]    [Pg.8]    [Pg.1647]    [Pg.41]    [Pg.131]    [Pg.196]    [Pg.3616]    [Pg.466]   
See also in sourсe #XX -- [ Pg.284 ]



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