The FDA expects the evaluation of the risk of nitrosamines in active pharmaceutical ingredients and finished drug products. This white paper describes how to conduct a nitrosamine risk assessment and perform the analysis for nitrosamines in APIs and drug products.
Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing laboratory. Our lab, located in Bristol, CT, is FDA registered and inspected and DEA licensed for Schedules 1 through V.
