spacer
home > ebr > summer 2020 > genotoxic impurities in drug products: review of nitrosamine assays
PUBLICATIONS
European Biopharmaceutical Review

Genotoxic Impurities in Drug Products: Review of Nitrosamine Assays

Nitrosamines are organic compounds that we are exposed to in our everyday lives. They are common in water and foods, including cured and grilled meats, dairy products, and vegetables.

Nitrosamines are classified by the ICH M7(R1) Guideline as class one impurities, ‘known mutagenic carcinogens,’ based on both rodent carcinogenicity and mutagenicity data (1). They are categorised by the International Agency for Cancer Research as 2A – probable carcinogens based on data on a number of species studied (2).

Nitrosamines became a news focus for medicine authorities in mid-2018, when a Chinese drug substance (DS) manufacturer detected the presence of N-nitrosodimathylamine (NDMA), in batches of valsartan (3). Meanwhile, different nitrosamines were detected in almost every drug product which contains a ‘sartan’ derivate as a DS.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Elodie Barrau is the Site Manager of Eurofins Amatsi Analytics in Toulouse area, France, with focus in chemistry, manufacturing and control, scientific support (GLP and GMP) for international preclinical, pharma, clinical development and/or registration, and implementation of analytical analysis. Elodie has a degree in Agronomist Engineering specialising in Phytochemistry Drug Development.

Emmanuel Desmartin is Mass Spec and Bioanalysis Lab Manager at Eurofins Amatsi Analytics, with 15 years of experience in bioanalysis; holding different positions in CROs as study director in development and validation of LC-MS methods, management of mass spec lab, and technical support.

Valentina Paschetta is Method Set Up and Validation Lab Manager at Eurofins Biolab, in Milan, Italy. Valentina began working as synthetic chemist in a pharmaceutical R&D department, before moving to analytical chemistry where she gained 15 years of experience in methods development and validation.

Davide Tartaglione is Senior Consultant at Eurofins Biolab. After graduating with a degree in biology, he gained experience in the regulatory field working in a consulting firm and contract manufacturing organisations. Davide is now part of Eurofins Consulting team with focus in the pharmaceutical area.

Mònica Coll Furest is Head of the Chemistry Laboratory at Eurofins BioPharma Product Testing Spain, in Barcelona. With a degree in Chemistry from Ramon Llull University, Spain, along with a Chemical Engineering and an Environmental Sciences degree from Institut Químic de Sarría, Spain. Monica has been in charge of the chemistry lab for more than 20 years, working in the pharma sector and also working in bioanalysis for 15 years.

Ana Novak, PhD, is Analytical Method Establishment Technician at Eurofins BioPharma Product Testing Spain, with a degree in Pharmacy from the University of Ljubljana, Slovenia, a doctorate in Pharmacy from the University of Barcelona, Spain, and several years of experience in method development and validation for the pharmaceutical sector.
spacer
Elodie Barrau
spacer
spacer
spacer
Emmanuel Desmartin
spacer
spacer
spacer
Valentina Paschetta
spacer
spacer
spacer
Davide Tartaglione
spacer
spacer
spacer
Mònica Coll Furest
spacer
spacer
spacer
Ana Novak
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

IMFINZITM (durvalumab) WITH CHEMOTHERAPY DEMONSTRATED A SUSTAINED OVERALL SURVIVAL BENEFIT IN 1ST-LINE EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN THE PHASE III CASPIAN TRIAL

Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence

Ludger Ltd

One of the most important classes of biopharmaceuticals is monoclonal antibodies. They are expressed from living cells, and are consequently subject to complex biochemical pathways. Not all of these routes are fully understood, and many are sensitive to the subtlest of environmental changes. Changes such as these can affect the final biopharmaceutical sequence, structure and post-translational modifications, not to mention any changes that may occur during further purification. This often means that the final product from one batch may be different from the last in another batch. Each batch is a complicated mix of similar molecules, and analysis of the degree of batch-to-batch variation is therefore very important to the establishment of the drug's safety for medicinal use and patient administration.
More info >>

 
Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement