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This publication describes the minimum requirements for validating noncompendial analytical test methods. It also describes a method for establishing the equivalency of alternate test methods. This publication is intended to meet the requirements of:

– Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 211.165(e), 211.194(a)(2), and 820.72(a); and
– Chapter 1225 (Validation of Compendial Methods) and portions of Chapter 621 (Gas Chromatography) in the USP-NF.

Product Details

Edition:

2nd

Published:

08/01/2013

Number of Pages:

20

File Size:

1 file , 490 KB