Gliclazide EP Impurity A, chemically defined as 4-Methylbenzene-1-sulfonamide (p-Toluenesulfonamide), is a key sulfonamide process and degradation impurity associated with Gliclazide, with molecular formula C₇H₉NO₂S and molecular weight 171.21 g/mol. This tosylamide is the sulfonamide starting material used to build the sulfonylurea moiety of Gliclazide, so residual unreacted material can be carried into the API; it is also formed by hydrolytic cleavage of the sulfonylurea bond of Gliclazide under acidic or alkaline stress. This makes it a significant marker for monitoring reaction completeness, starting-material carryover, and hydrolytic degradation in stability studies. Manufactured at Chemicea under tightly controlled synthetic and analytical protocols, this reference standard supports impurity identification, method validation (AMV), and quality-control testing in compliance with EP and BP monograph requirements for Gliclazide, and is routinely used in DMF and marketing-authorisation submissions. Each batch is supplied with a comprehensive Certificate of Analysis supported by HPLC, ¹H-NMR, and Mass Spectrometry characterization data, ensuring dependable analytical traceability for pharmaceutical laboratories worldwide. CAS No. 70-55-3 | Explore complete technical documentation, Safety Data Sheet (SDS), and pricing.