A Review of FDA Requirement on Recommended Acceptable Intake Limits for Nitrosamine Drug Substance Related Impurities

In this review article, it shows the evaluation and risk associated with potential formation of Nitrosamine Impurities in different pharmaceutical dosage forms. The control of Nitrosamine Impurities in drug substances and drug products are mandatory as per the Food and Drug Administration (FDA) Centre for Drug Evaluation and Research (CDER) guidelines. Due to Carcinogenicity and Toxicity, the risk assessment and evaluation of Nitrosamine impurities’ potential presence in finished dosage drug products is necessary. Thus, FDA has issued the guidance on the Control of Nitrosamine Impurities in Drug Product and Recommended Acceptable Intake Limits (RAIL) for Nitrosamine Drug Substance Related Impurities (NDSRI).