Nitrosamine Analysis

Nitrosamine analysis is performed to verify the safety of pharmaceutical products. These are potentially carcinogenic impurities that can form under specific conditions during manufacturing, storage, or chemical reactions. Consequently, their monitoring is critical for product quality, patient safety, and regulatory compliance.

What are Nitrosamines?

Nitrosamines are chemical compounds formed from amines and nitrites. They can occur, for example, in active pharmaceutical ingredients (APIs), excipients, or the final product. Some of these compounds are classified as mutagenic or carcinogenic because they can damage genetic material or increase the risk of cancer.

Analytical Methods for Nitrosamine Analysis

Nitrosamine analysis requires highly sensitive and specific analytical methods to detect even trace amounts of these impurities. Typical analytical techniques include:

• GC-MS (Gas Chromatography/Mass Spectrometry)
• LC-MS/MS (Liquid Chromatography/Mass Spectrometry)
• HEADSPACE-GC for volatile nitrosamines

The analysis must also be designed for validation to ensure that the results are reproducible, robust, and conclusive.

Regulatory Requirements

European (e.g., EMA, Ph. Eur.) and international regulations (e.g., US FDA) mandate stringent controls for nitrosamines in pharmaceuticals. Authorizations, specifications, and risk assessments are also based on the results of these analyses to ensure patient safety.

Our Scope of Services

Nitrosamine Analysis: EP, USP, BP, JP

Nanolab – Your Partner for Nitrosamine Analysis

Nanolab, as a specialized analytical laboratory, is your competent partner for the testing of nitrosamines in pharmaceuticals. Our experts conduct these analyses using state-of-the-art technologies, adhering to stringent GLP standards and regulatory requirements.

Trust Nanolab for fast, accurate, and legally compliant results — ensuring the safety of your products at all times.