Webinar on Azido Impurities

[Naiffer_Host]

@DAB Thanks for sharing the link to the event.

Date: 8th December 2021
Time: 9am BRT | 5:30pm IST | 1pm CET

Webinar Topics:
#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:
Fernanda Waechter - Lhasa @fernandaw
Raphael Sanchez Pereira - GQMED/GGMED
Rakeshwar Bandichhor - VP and Head of Chemistry, API-PR&D, Dr. Reddy’s

We have few discussions on the topics throughout the community:

Is AZBT (azidomethyl-biphenyl-tetrazole) the new Nitrosamine?

We are starting to see some noise on this Azido impurity. This is the information I have been able to collect so far: CMDh - notified authorization holders that Azido impurity in irbesartan confirmed positive in bacterial mutagenicity test – https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Advice_from_CMDh/CMDh_430_2021_Rev.0_2021_04_Request_for_investigation_Sartans-Azido_impurity_in_irbesartan_confirmed_positive_in_bacterial_mutagenicity_tests.pdf SwissMedic - Notified about f…

Another azido impurity detected in losartan potassium, Ames test +

29Sep21… In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a few sources were impacted. A number of measures were taken to ensure that any active substance containing these impurities above the acceptable level would not be released onto the market. In a…

Test methods for Nitrosamines & Azido compounds in Sartans published by Taiwan FDA

https://www.fda.gov.tw/ENG/siteList.aspx?sid=10360&utm_source=emailcampaign111&utm_medium=phpList&utm_content=HTMLemail&utm_campaign=EDQM+Newsletter+September+2021

TGA, Australia Recalls Sartans due to Azide Impurity

In August 2021 TGA started Investigations on Azide Impurity issues in Sartans after recalling impacted products. Enclosed is the update from the Agency: