In October 2021, a number of batches of irbesartan and irbesartan hydrochlorothiazide finished products were recalled from the US market, due to the presence of an
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In the current study, we performed a set of 10 reactions of irbesartan with nitrous acid under various conditions and found no trace of this “N-nitrosoirbesartan” by a
Chemical Name: 2-Butyl-3- ( (2'- (2-nitroso-2H-tetrazol-5-yl)- [1,1'-biphenyl]-4-yl)methyl)-1,3-diazaspiro [4
They postulated that the N -nitrosation process was not feasible due to
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All N-nitroso derivatives were fully separated from their respective APIs
0g of irbesartan was accur-ately weighed into a 10-mL volumetric flask and 10mL of NDMA-d 6 solution was added
Sub-stances (n=67) from various pharmaceutical classes were evaluated and 49
3 ppm
Louros November 22, 2023, 7:39am 1
BACKGROUND N-nitroso compounds are considered to have extremely high carcinogenic potency, and several medications have been subject to recalls due to the presence of these impurities
54 g/mol: Mol
If you’ve been trying to go completely The review of sartans concerned candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists)
77; Molecular formula : C15H20ClNO3 It is a N-Nitroso of secondary amine present in Irbesartan
1,2 To ensure the safety of pharmaceutical products, steps must be taken to understand the source of these impurities and to ensure their removal from the final drug substance