New Azido impurity Pharma Genotoxic Impurity application note on TSQ Quantis™ LC-MS/MS
Key benefits
• A single method capable of detecting an azido impurity (AZBT) in six different
Sartan products—Candesartan, Irbesartan, Losartan, Olmesartan, Telmisartan, and Valsartan—saves time by testing multiple products in one sequence without separate
method development.
• A robust method for quantification of AZBT was achieved by using a divert valve to
prevent the mass spectrometer from the build-up of high concentrations of drug
product samples. This helped maintain good sensitivity and reproducibility.
• This study is in line with regulatory information and requirements mentioned in
EDQM1, USFDA (Q2B)2, EMEA3, and ICH M74 guidelines.
It’s been 3+ years since the Azido impurities raised as a concern while we were all talking about Sartans and Nitrosamines.
This publication by Chourasiya et al review article critically accounts for (i) the toxicity of azido impurities and the proposed mechanism of mutagenicity, (ii) the regulatory perspective, and (iii) the sources and control strategies used during the preparation of drug substances and (iv) future perspectives.