Analytical methods for testing medical gases are described in medical gas monographs contained in the United States Pharmacopeia and National Formulary. These analytical methods are called compendial methods. When using a test method other than a compendial method, a firm has to demonstrate (validate) that the test method it is using is equivalent to the corresponding compendial method. 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.