GUIDELINE FOR STABILITY DATA
(e.g., Efficacy of Antimicrobial Preservation of the BP or Antimicrobial Preservative Effectiveness Test of the USP) and by performing chemical assays for the preservatives during the regular stability testing schedules. If a lack of or low levels are found, testing for sterility should be carried out. iv) Dissolution testing
Preservation, Antimicrobial, Efficacy, Efficacy of antimicrobial preservation
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