Nitrosamines Impurities Testing

Our services enable you to accurately identify and measure any impurities in pharmaceutical products quickly and conveniently.

What are Nitrosamines?

Nitrosamines, or more precisely, N-nitrosamines, refer to any molecule containing a nitroso functional group.

They are chemical compounds classified as probable human carcinogens based on animal studies and have become a focus for regulatory agencies due to their potential danger. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.

Simple Nitrosamines

Some nitrosamines can be formed by the reaction of the secondary amine group contained in commonly used solvents or reagents during organic synthesis. These are usually named simple nitrosamines. The most important ones, initially controlled by FDA and Health Canada, are NDMA, NDEA, NDIPA, NEIPA, NDBA, NMPA and NMBA. However, several nitrosamines related to other solvents were added with time.

Complex Nitrosamines

Secondary amines groups contained in drug substances or their related substances can also react with nitrous acid during the organic synthesis of the API to generate nitroso adducts. These nitroso impurities are commonly named complex nitrosamines due to their specificity to each API structure and organic synthesis conditions.

HEALTH AUTHORITIES' REQUESTS

As outlined on their website, health authorities (FDA, EDQM) are asking the following from Market Authorization Holders (MAH) regarding the Nitrosamines Issues.

A risk assessment should be conducted on all API and drug product manufacturing processes in order to identify potential sources of contamination.
Perform confirmatory testing on commercial drug product batches using a validated method.
Inform the appropriate health authorities of any changes to the marketing authorizations following risk assessment and confirmatory testing performed.

Averica: Reliable and Accurate Nitrosamines Impurities Testing

Averica is your go-to source for nitrosamines impurities testing. Our advanced and reliable testing services will give you the peace of mind knowing that your pharmaceuticals are safe from these harmful compounds. With our timely and accurate results, you can be sure that your products are compliant and meet all applicable regulatory requirements.

Risk Assessment Made Easy

Our nitrosamines screening process makes risk assessment easier and more reliable. We adjust sample preparation and instrumental parameters for each product of interest, ensuring accuracy and reliability.

Confirmatory Testing Available

We provide confirmatory testing to verify the results of our screening process. Our method validation process ensures that your testing is accurate, reliable, and safe.

Time-Saving Process

Our nitrosamines impurities testing is fast, efficient, and cost-effective. We save you time by providing a streamlined process that gets results quickly and accurately.