Thursday, 19 November 2015

Pharmacopeial Forum 41 (6)



A new edition of the Pharmacopeial Forum has been issued.  This is volume 41, issue 6, which covers the period November - December 2015.

Highlights include:

Chapter 151 Pyrogen Test
(Revision proposal target, USP40-NF35)

To encourage the use of in vitro alternatives to in vivo animal tests, a revision is proposed to introduce text into the Introduction of the chapter that allows the use of a validated, equivalent in vitro pyrogen or bacterial endotoxin test in place of the in vivo rabbit pyrogen test, where appropriate. There is no impact on any of the monographs that reference this chapter.

Chapter 1790 Visual Inspection of Injections [NEW]
(Revision proposal target, USP40-NF35)

The General Chapters—Dosage Forms Expert Committee proposes this new chapter to provide guidance on the inspection of injectable drug products for visible particles. The methods discussed are also applicable to detection of other visible defects that may affect container integrity or cosmetic appearance of the product. 

Posted by Dr. Tim Sandle

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