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Nitrosamines are organic compounds with a chemical structure comprising a nitroso group bonded to amine and alkyl groups. They are usually produced by the reaction of nitrous acid and secondary amines. Studies have shown that approximately 90% of the 300 nitrosamines tested were carcinogenic in a wide variety of animals.
Primera has developed a cost effective analytical strategy to analyze nitrosamines in your APIs and drug products. Our experienced staff developed a rapid screening method that detects all nitrosamine impurities listed in the FDA August 2023 guidance as well as those nitrosamines required by the EMA. This screening method ensures that the nitrosamines are detectable in the API and/or finished product samples by utilizing a spike and recovery approach.
We also work on API specific nitrosamines. Primera will work with you to obtain the specific nitrosamines or work with one of our approved vendors to synthesize the targeted nitrosamines. We will then utilize our expertise to develop and validate a method(s).
Primera Has Successfully Screened and Validated Many APIs and Drug Products
Our highly efficient methods for detecting nitrosamines to satisfy regulatory requirements will set your mind to ease. Our approach has been utilized by small, mid-size, and large pharmaceutical clients yielding positive approvals by the FDA. We encourage all to conduct a comprehensive risk assessment prior to API or product testing to determine the possible nitrosamines in your API or drug product. A risk assessment will assist your understanding of the possible nitrosamines in your product and create a more cost effective analytical strategy when testing.
Initially our screening method will ensure that the nitrosamines are detectable in the API and/or finished product samples by utilizing a spike and recovery approach. If nitrosamines have been detected once the screening has been completed on a material, Primera will work with you to develop and validate a method for the appropriate nitrosamine(s). We typically utilize LC-MS/MS or GC-MS to detect the nitrosamines.
We also work on API specific nitrosamines. Primera will work with you to obtain the specific nitrosamines or work with one of our approved vendors to synthesize the targeted nitrosamines. We will then utilize our expertise to develop and validate a method(s).
Ann Draghi, Sr. Director of LC-MS/MS Service, earned an M.S. from City University of New York. Prior to joining Primera, Mrs. Draghi worked for Purdue Pharma (8 years) and Novartis (11 years) as a Principal Scientist, specializing in LC-MS/MS method development and validation, as well as coordinating routine sample analysis to support preclinical and clinical studies. She has over 25 years experience in regulated pharmaceutical development with broad experience in FDA GMP and GLP regulation. Mrs. Draghi’s knowledge and experience also covers a broad range of pharmaceutical analysis, including liquid chromatography, mass spectrometry (especially in traceable amount impurity quantitation for API and finished products), and method transfer/verification based on USP/EP procedures.
Our Nitrosamine Expert, Ann Draghi
Primera’s Extensive Experience in cGMP and Dedication to Clients Creates a High Level of Client Trust and Satisfaction
Our people are determined to ensure that timelines are met and will provide quality data always striving to exceed our client’s expectations.
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