Nitrosamine virtual Interest Group Meeting

We are now happy to present you the final agenda of the meeting, exclusively designed to help you enhance your expertise for improved outputs.

14:30 -14:45 Opening

14:45 -15:15 Challenges in Nitrosamine Detection in Drug Substances and Drug Products

Nitrosamine impurities are known to be mutagenic and carcinogenic impurities, which can be found into drug substances and drug products due to reagents, solvents or raw materials used in the manufacturing process. Because of the low detection limits required, GC/MS or LC/MS are the preferred techniques. The challenge in the method development is due to complexity of some drug products and the relatively high dosages: some case histories are discussed during the presentation, as well as the validation of the methods themselves.

Presenter: Luisa Zangirolami (General Manager and Qualified Person, PRC Ticinum Lab Pharma Research)

Luisa Zangirolami is more than 30 years in the Pharmaceutical industry. She started with QC and analytical development roles, and then she hold positions in pharmaceutical sciences, including Drug Substance and Drug Product clinical and commercial manufacturing.

Currently she is leading the CRO PRC Ticinum Lab in Novara ( Italy) , as General Manager and Qualified Person.

15:15 -15:45 Nitrosamine Issue from an Analytical CRO Site

To provide industry insights about the current and future impact of nitrosamine’s regulation on the business
Approach followed / proposed for the implementation of the new regulation: way forward to handle these impurities and the regulatory aspects, challenges encountered.

Presenter: Elodie Barrau (Eurofins Amatsi Analytics Fontenilles Site Manager, Eurofins Amatsigroup)

Elodie Barrau is the Site Manager, of Eurofins Amatsi Analytics in Toulouse area (France), with focus on CMC, scientific support (GLP and GMP) for International preclinical, pharmaceutical, clinical development and/or registration and implementation of analytical analysis. Elodie has a degree of Agronomist engineer specialized in phytochemistry, drug development

15:45 -16:15 Analytical Strategies for the Accurate Determination of Nitrosamines Produced in the Manufacture of APIs and Drugs

Pharmaceutical companies are coming under increased scrutiny by regulators across the world to accurately identify and quantify mutagenic impurities in drug substances and products. Recently, several sartan, ranitidine, and metformin-based drug products were recalled due to the presence of nitrosamine contaminant in unacceptable amounts in these drugs. Consequently, the USFDA and other regulatory agencies published analytical testing methods to provide guidance to regulators and industry to evaluate mutagenic nitrosamine impurities in drug substances and drug products. In this presentation, we will cover the recent regulations for the detection of nitrosamines. We will also review the relevant GC/MS and LC/MS based analytical strategies for the identification and quantification of these nitrosamines in APIs and drugs.

Presenter: Parul Angrish (PhD Pharma Marketing Manager, Agilent Technologies)

Parul Angrish is a Pharma Marketing Manager at Agilent Technologies. Her focus includes advancing Agilent’s strategic solutions to meet customer needs primarily in small molecule pharma end market. She has over 15 years of extensive experience in innovating, commercializing and leading cross-functional teams to drive business growth opportunities. Prior to joining Agilent Technologies, she had held several positions at Thermo Fisher Scientific, Life Technologies and DiscoveRx Corporation. Shereceived her Ph.D. in chemistry from the University of Florida. She has co-authored several peer-reviewed articles and is an inventor on several patents

16:15 -16:45 Q&A Session

16:45 Closing