Nitrosamine CRMs designed for Regulatory Requirements

September 27th, 2023

AccuStandard offers N-nitrosamine CRMs designed for the latest regulatory requirements. 2023 has been an eventful year for research and regulation of nitrosamines in food and drugs. The European Food Safety Authority (EFSA) and the German Federal Institute on Risk Assessment (BfR) both expressed concern for health risks related to human exposure to nitrosamines in food.

AccuStandard products for N-nitrosamine CRMs are designed to help achieve accurate results when testing for these compounds, and in accordance with different test methods such as USEPA 521, 607, 8070, 8270 and ASTM D8456. Additionally, we have an expanding selection of single component CRMs for both native and deuterated N-nitrosamine compounds available to assist in method development and the reliable identification of the individual compounds.

March 2023

March 28, 2023 the European Food Safety Authority (EFSA) published its Risk assessment of N-nitrosamines in food. During this assessment, 32 nitrosamines were studied and 10 were confirmed to be carcinogenic and genotoxic to animals, both in vitro and in vivo. Among those confirmed to cause cancer were NDMA (CAS# 62-75-9), NMEA (CAS# 10595-95-6), NDEA (CAS # 55-18-5) and NDPA (CAS# 621-64-7).

April 2023

April 11, 2023 the German Federal Institute on Risk Assessment (BfR) published opinion No. 016/2023 where their evaluation confirmed the EFSA’s findings.

August 2023

August 4, 2023 the FDA issued a final guidance on “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)” and specified August 1st 2025 for all drug manufacturers to meet the new FDA AI limits. See their Guidance for Industry on AI Limits for NDSRIs.