Nitrosamine Analysis in Pharmaceuticals According to ICH M7: An Important Step for Patient Safety
The discovery of nitrosamines, potentially carcinogenic substances, in pharmaceuticals has prompted the pharmaceutical industry to develop stricter testing procedures. The ICH M7 guidelines (International Council for Harmonisation) now provide clear requirements for the identification and quantification of nitrosamines in pharmaceutical products to ensure patient safety.
What Are Nitrosamines and Their Risks?
Nitrosamines are formed through the reaction of secondary amines and nitrites, often during pharmaceutical production. These impurities are considered genotoxic, meaning they can damage genetic material, increasing the risk of cancer and other health issues.
Requirements of ICH M7
The ICH M7 guidelines outline specific requirements for nitrosamine analysis:
Risk Assessment: Pharmaceutical companies must conduct a risk assessment of the manufacturing process to identify potential sources of nitrosamine formation.
Testing Methods: Validated analytical methods such as LC-MS/MS (Liquid Chromatography with Tandem Mass Spectrometry) and GC-MS (Gas Chromatography-Mass Spectrometry) are recommended for detecting nitrosamines. These methods offer high sensitivity and precision. Common target nitrosamines include N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitrosopyrrolidine (NPYR).
Limits: The guidelines set strict limits for nitrosamine concentrations, typically around 1.0 µg/day per dose, depending on the type of pharmaceutical and its intended use.
Ongoing Monitoring: Regular testing and process controls are required to ensure consistent product quality and safety.
GMP-Certified Services for Nitrosamine Analysis
As a GMP-certified and FDA-registered laboratory, we offer comprehensive services for nitrosamine analysis that meet both regulatory requirements and specific analytical challenges. We are familiar with the latest standards and guidelines and utilize advanced techniques such as LC-MS/MS and GC-MS to precisely measure nitrosamine concentrations in your pharmaceutical products. With our tailored solutions, we ensure that your pharmaceuticals comply with international safety standards.