AZIDO Impurities Topic

AZIDO Impurities making their way into the news again, we see several agencies reacting to this topic and market withdrawal been posted.

Some of our previous AZIDO related posts:

@fernandaw can we get access to the recording of the webinar?

Are you dealing with AZIDO impurities? :roll_eyes:


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@Naiffer_Host This is an excellent compilation Naiffer like a timeline on Azido impurities that we have seen so far

New Azido impurity Pharma Genotoxic Impurity application note on TSQ Quantis™ LC-MS/MS :arrow_down:

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.

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an-000748-pb-lc-ms-vanquish-tsq-drug-products-an000748-na-en.pdf (929.1 KB)

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