EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
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The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
The MHRA have announced another sartan-containing drug product over fears that it is contaminated with the carcinogen N‑nitrosodiethylamine...