2012 3 2 Test For Sterility Final

3.2 TEST FOR STERILITY - World Health Organization

D ocument QAS/11.413 FINAL March 2012 3.2 TEST FOR STERILITY Final text for revision of The International Pharmacopoeia This monograph was adopted at the Forty-sixth WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2011 for addition to the 4th Edition of the International Pharmacopoeia.

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85 BACTERIAL ENDOTOXINS Change to read: TEST …

Stage 6 Harmonization Official December 1, 2012 〈85〉 Bacterial Endotoxins Test1 〈85〉 BACTERIAL ENDOTOXINS Change to read: TEST PREPARATION OF SOLUTIONS Standard Endotoxin Stock Solution—A Standard Endo- toxin Stock Solution is prepared from a USP Endotoxin Refer- Change to read: ence Standard that has been calibrated to the current WHO …

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<1151> PHARMACEUTICAL DOSAGE FORMS - DrugFuture

50.0 mL or more 2% 3% tention times from two chromatographic procedures for which the separation is based on different principles or a Labeling Statements—Some dosage forms or articles combination of tests in a single procedure can be accept-