Mérieux NutriSciences
Pharma & Healthcare | One-stop shop solution
Nitrosamine impurities analysis on APIs and drug products
Mérieux NutriSciences’ GMP Labs offers advanced solutions through a cutting-edge technology to guarantee the safety and conformity of your pharmaceutical products
On September 26th, 2019 the CMDh (Heads of Medicines Agencies) published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products.
Soon after, similar requirements have been extended rapidly and globally to other Countries, drug products (e.g. biological medicinal products) and new complex nitrosamines (NDSRIs) requiring high levels of expertise, technology and capacity in order to ensure product safety and mandatory deadlines.
Discover Our Value: Mérieux NutriSciences Highlights
60+
Developed methods for the analysis of NSDRIs
7
LC-MS/MS instruments for nitrosamines tests
12.000+
Tests on Pharmaceutical products and APIs
6
Several analytical techniques as GC-MS, LC-MS
25
Senior Experts & Technical Analysts
3
R&D, QC and in vitro genotox labs
15
Years of Experience
Mérieux NutriSciences Pharma Nitrosamines Labs Global Service
Multiresidual Analysis
NDMA, NDEA, NDELA, NMOR and many others
Targeted methods for almost 50 NDSRIs
Expertise, capacity, and emergencies management
Acknowledgements & Authorizations
The risk evaluation process
RISK EVALUATION
MAHs should perform risk evaluation of their medicinal products containing chemically synthesised APIs.
CONFIRMATORY TESTING
Confirmatory tests should be carried out using validated and sensitive methods. MAHs should inform the competent authorities immediately if tests confirm the presence of a nitrosamine impurity irrespective of the amount detected.
CHANGES TO THE MARKETING AUTHORISATION
MAHs should apply for a variation in a timely manner to introduce any required changes, such as amendment of the manufacturing process or changes to product specifications.
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MxNS | Pharma & Healthcare
One-stop shop solution
As valued partner to the global pharma industry, Mérieux NutriSciences | Pharma & Healthcare offers research, development and quality control testing.
From active ingredients to finished products, our Pharma GxP Labs - more than 20.000 sqm based in Italy - present a complete spectrum of analytical and research services that include safety and quality control, analytical methods development and validation, and bioanalytical testing.
Discover all MxNS testing services: quality controls - investigation studies - absorption studies - R&D and validation activities - stability & storage conditions - cleaning and disinfectants validation - environmental services for pharma facilities.