Nitrosamines – Qvents

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2 minutes read Guidelines

Updated on June 12, 2025

Updated on June 12, 2025

USFDA: Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs;
USFDA Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (Aug 2023) – Guidance Document
USFDA: CDER Nitrosamine Impurity Acceptable Intake Limits | FDA
USP General Chapter <1469> Nitrosamine Impurities – Presentation; (Also Refer USP General Chapter)
EMA (European Medicines Agency) Nitrosamine impurities
EMA Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
EMA Guidance for marketing authorisation holders
EMA: Appendix 1: Acceptable intakes established for N-nitrosamines (Nitrosamine impurities: Guidance for marketing authorisation holders)
EMA Active substance-derived nitrosamines
CMDh Information On Nitrosamines For Marketing Authorisation Holders
EMA (Adopted by CHMP) Assessment report Nitrosamine impurities in human medicinal products
European Pharmacopeia General Monographs : Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) for Ph. Eur. approach to N-nitrosamine impurities (Access through Ph Eur (EP)
OMCL/EDQM: Methods for determination of nitrosamines and NDSRIs
APIC (CEFIC): Nitrosamine Risk Management: Guidance for API Manufacturers (2025)
APIC (CEFIC) Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs
APIC (CEFIC) Template for Nitrosamine Risk evaluation of APIs
IPEC Europe: Questionnaire for Excipient Nitrosamines Risk Evaluation
IPEC Americas: Federation Announces Updated Nitrosamines Questionnaire
WHO Information Note Nitrosamine impurities
WHO WHO Good Practice Considerations for the Prevention and Control of Nitrosamines in Pharmaceutical Products (TRS 1060 – Annex 2)
Health Canada Nitrosamine impurities in medications: Guidance
OPR &D Article: Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines, Olivier Dirat et al., Organic Process Research & Development, Articles ASAP (Article); May 23, 2025

Tags : NDSRI, Nitrosamines

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