Telmisartan EP Impurity E

Detection, isolation and characterization of principle synthetic route indicative impurity in telmisartan
V.Srinivasan, H.Sivaramakrishnan, B.Karthikeyan
Arabian Journal of Chemistry Volume 9, Supplement 2, November 2016, Pages S1516-S1522
 
Quality-by-design approach for the development of telmisartan potassium tablets
Ga-Hui Oh, Jin-Hyun Park, Hye-Won Shin, Joo-Eun Kim, Young-Joon Park
Drug Dev Ind Pharm. 2018 May;44(5):837-848.
 
An Efficient and Impurity-Free Process for Telmisartan:  An Antihypertensive Drug
Kikkuru Srirami Reddy, Neti Srinivasan, Chinta Raveendra Reddy, Naveenkumar Kolla, Yerremilli Anjaneyulu, Sundaram Venkatraman, Apurba Bhattacharya, and Vijayavitthal T. Mathad
Org. Process Res. Dev. 2007, 11, 1, 81–85
 
Simultaneous determination of Telmisartan impurities and Chlorthalidone impurities by UPLC
B. Marineni, T. Sreenivasulu Reddy
International Journal of Pharmaceutical Sciences Review and Research 26(2):226-230

Telmisartan EP Impurity E is chemically 1-[(2′-carboxy[1,1′-biphenyl]-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazole-6-carboxylic acid (as per EP) ; 1-[(2′-Carboxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid (as per USP). It is also known as Telmisartan Diacid (USP). Telmisartan EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Telmisartan EP Impurity E can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Telmisartan.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.