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Sartans: New Mutagenic Impurities
– Azido Impurities

On demand webinar recording - now available

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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

Fernanda is a Pharmacist and her professional experience began in 2015, when she started working at Prati-Donaduzzi and her industry experience in pharmaceutical industry was mainly in the evaluation of drug master files for compliance with ICH and ANVISA regulations. In 2017, she moved to São Paulo to work at Aché Laboratories, where she developed her master's project in partnership with the University of São Paulo, entitled "Risk assessment of potentially mutagenic impurities in antihypertensive drugs approved in Brazil". This project allowed her to have more experience with the ICH M7 and was what motivated her to create scientific videos on this and other topics related to her work, which are available on her YouTube channel. In 2020, she was part of the Nitrosamines Working Group with ANVISA, representing Sindusfarma. In 2021, she joined Lhasa Limited as Principal Application Scientist, where she now works supporting software users in decision making through in silico solutions.

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Raphael Sanchez Pereira

Manager of Quality Assessment of Synthetic Medicines
GQMED/GGMED

Pharmacist-Biochemist, graduated in Pharmacy-Biochemistry from the Faculty of Pharmaceutical Sciences, University of São Paulo, University of São Paulo FCF-USP.
He worked as an analyst and later as a specialist in analytical development in the Brazilian pharmaceutical industry, between May 2010 and December 2013. He worked mainly in the development and validation of analytical methods, especially those related to degradation products in medicines.
He has been working as a Specialist in Health Regulation and Surveillance at ANVISA since April 2014, and is the Manager of Quality Assessment of Synthetic Medicines (GQMED/GGMED), responsible for the analysis of the quality part (CMC / pharmaceutical technology) of synthetic medicines.

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Rakeshwar Bandichhor

PhD, FRSC, CChem
VP and Head of Chemistry, API-PR&D, Dr. Reddy’s

Dr. Rakeshwar Bandichhor, possui doutorado em química pela University of Lucknow / University of Regensburg, Alemanha, e trabalhou como pós-doutorado na University of Regensburg, Germany, University of Pennsylvania e Texas A&M University. Ele é co-autor de mais de 170 artigos, incluindo patentes e capítulos de livros publicados / aceitos em várias revistas internacionais, e contribuiu para mais de 100 conferências acadêmicas nacionais e internacionais.
Rakeshwar ganhou vários prêmios e homenagens em sua carreira. Em química verde, isso inclui o Roll of Honor Award pela área de Green Chemistry 2012, o Green Innovation Award 2013 pelo IGCW-2013. Ele também ganhou o prêmio STE Green Excellence em 2019.

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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.