Sartans: New Mutagenic Impurities – Azido Impurities
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We are bringing to Brazil the first Webinar on a new class of mutagenic impurities discovered in drugs from the class of Angiotensin II Receptor Antagonists, popularly known as Sartans, which are widely use drugs for the treatment of hypertension, heart and kidney diseases.
Since November 2020, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has been highlighting the importance of the potential formation of mutagenic impurities in Sartans, and since July 2021, there has been the recall of multiple batches of this class of API's in Canada and more recently in October 2021 in Brazil and the United States.
With the purpose of mapping the impacts and necessary actions, in this Webinar we bring the expertise of specialists in the areas of Organic Synthesis and API Production, Toxicology, Regulation and Sanitary Actions in the view of ANVISA.
What you will learn:
#1 Azido and nitrosamine impurities: Formation, similarities, differences and its carcinogenicity.
#2 Work flow and risk assessment to tackle these impurities
#3 ANVISA Positioning and updates on Azido impurities
Speakers
Ms Fernanda Waechter
Principal Application Scientist Lhasa Limited
Raphael Sanchez Pereira
Manager of Quality Assessment of Synthetic Medicines GQMED/GGMED
Rakeshwar Bandichhor
PhD, FRSC, CChem VP and Head of Chemistry, API-PR&D, Dr. Reddy’s
Summary of the Webinar
In this Webinar, Dr. Reddy's in collaboration with Sindusfarma, brings the expertise of specialists in the areas of organic synthesis and API production, toxicology, regulatory, and sanitary actions in the view of ANVISA; to discuss the topic – "Sartans: New Mutagenic Impurities - Azido Impurities."
In the first section of the Webinar, Ms. Fernanda Waechter, Principal Application Scientist, Lhasa Limited, talks about - Azido and nitrosamine impurities: formation, similarities, differences, and their carcinogenicity. Then, she focuses on performing the risk assessment, stages, and problems in controlling the azido impurities. ICH M7 guidelines, azido impurities Vs. nitrosamines, recalls due to azido impurities, sartans and where they come from, acceptable intake, and risk assessment applicable for impurities.
In the next section, Rakeshwar Bandichhor, Ph.D., FRSC, CChem, VP, and Head of Chemistry, API-PR&D, elaborates on the Workflow and risk assessment to deal with these impurities. In addition, he talks about the alkyl azide chemistry connected with biology (potential mutagenicity), The chemistry behind Azido impurities formation in Sartan APIs, and the control strategy for Azido impurities in key starting materials (KSMs) of Valsartan.
Rakeshwar concludes the Webinar with the case studies on confirmatory testing of Valsartan & Losartan Potassium and Dr. Reddy's assessment of Sartan APIs in line with ICHM7. The Azido impurities assessment reports for Losartan potassium and Valsartan, control strategy – TD50 and its relation to nitrosamine impurities.
In the final section of the Webinar, Raphael Sanchez Pereira, quality assessment manager for synthetic medicines, GQMED, ANVISA talks about ANVISA positioning and updates on azido impurities, current scenario, and uncertainties about mutagenicity/carcinogenicity. Latest updates on API products under ANVISA investigation, registrations and post-approval changes, regulatory approaches, and many more.
Dr. Reddy's has continued to manufacture and deliver Sartan APIs following global regulations with the help of our expertise in process engineering and analytical chemistry to avoid nitrosamine and azido impurities. We stay committed to ensuring that we continue to provide high-quality and safe APIs to our partners.
For chemistry and analytical assessment reports on this topic and any other queries, please get in touch with our account managers or reach us at api@drreddys.com.
