Pharma Specialists

Nitrosamine

How to Set Specifications for Nitrosamine Impurities in Drug Products?

Regulatory agencies expect companies to control these impurities…

July 10, 2026

Nitrosamine

Nitrosamine Risk Assessment: Single Unit Testing vs Maximum Daily Dose (MDD)

One of the most frequent technical questions I encounter during …

December 15, 2025

Nitrosamine

Nitrosamines in Pharmaceuticals | USFDA Perspective

Nitrosamines are a class of chemical compounds (probable human c…

February 28, 2024

Health Canada

Health Canada Guidance on Nitrosamine Impurities

This guidance represents Health Canada’s current thinking and re…

May 02, 2023

Nitrosamine

Nitrosamine Impurities | EDQM Supplements General Monographs 2034 and 2619

At its 174th meeting in November 2022, the European Pharmacopoei…

February 01, 2023

EMA

Questions and Answers on Nitrosamine Impurities for Marketing Authorization

EMA Updates on nitrosamine impurities along with Questions and a…

October 16, 2022

Nitrosamine

Determination of Nitrite in Pharmaceuticals

N-nitrosodimethylamine (NDMA) is an organic compound with the …

October 10, 2022

Impurities

Nitrosamine Risk Assessment for Human Drug Products

Nitrosamine impurities for human drug products considering the r…

September 10, 2022

Nitrosamine

Regulatory Focus on Nitrosamine Impurities

FDA initially were very keen on Elemental impurities and over th…

August 22, 2022

IPEC

The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products | IPEC Position Paper

N-nitrosamines are a class of organic compounds that include exa…

March 03, 2022

Contamination

How do you control multiple nitrosamine contaminants in a product?

The EMA/CMDh question and answer document on nitrosamine impurit…

February 23, 2022

Contamination

Nitrosamines in Herbal Medicinal Products | Regulatory Compliance

The EMA Committee on Herbal Medicinal Products (HMPC) has prepar…

February 10, 2022