Laboratory Methods (Drugs)

Listed below are analytical laboratory methods developed and used by FDA to test certain drug quality attributes that also may impact safety. These FDA testing methods are intended to detect impurities in certain drug substances and certain drug products. For information on submitting these or any other analytical laboratory methods and methods validation data to support new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) , please refer to the guidance Analytical Procedures and Methods Validation for Drugs and Biologics (July 2015).

Ethylene Glycol and Diethylene Glycol

• [March 2025] Gas Chromatography-Mass Spectrometry (GC-MS) Method for the Determination of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in Cough, Cold, and Allergy Products containing Glycerin (PDF - 31KB)

Nitrosamine

• [September 2024] Recommended Analytical Testing Methods for Confirmatory Testing of Certain Nitrosamine Impurities

Impurities in Alcohol-Based Hand Sanitizers

• [January 2022] GC-MS Method to Evaluate the Interconversion of Impurities and the Product Quality of Liquid Hand Sanitizers
• [September 2021] Spatially Offset Raman Spectroscopy (SORS) and Support Vector Regression (SVR) Method for Through-Container Analysis of Hand Sanitizers