Clopidogrel EP Impurity F

Separation and determination of clopidogrel and its impurities by capillary electrophoresis
Ahmed S. Fayeda,b,∗, Soheir A. Weshahy b, Mostafa A. Shehata b, Nagiba Y. Hassanb, Jochen Pauwels a, Jos Hoogmartens a, Ann Van Schepdael
Journal of Pharmaceutical and Biomedical Analysis 49 (2009) 193–200
 
Identification and characterization of a principal oxidation impurity in clopidogrel drug substance and drug product
Arivozhi Mohan ∗, M. Hariharan a, E. Vikraman a, G. Subbaiah a, B.R. Venkataraman b, D. Saravanan
Journal of Pharmaceutical and Biomedical Analysis 47 (2008) 183–189
 
The Efficacy and Safety of Clopidogrel Resinate as A Novel Polymeric Salt Form of Clopidogrel
Min-Hyo Ki, Mee-Hwa Choi, Kwang-Bok Ahn, Byoung-Su Kim, Dai Sig Im1 , Soon-Kil Ahn1 , and Hee-Jong Shin
Arch Pharm Res Vol 31, No 2, 250-258, 2008
 
New and Efficient Synthetic Approaches for the Regioisomeric and Iminium Impurities of Clopidogrel Bisulfate
Sampath Aalla,‡ Goverdhan Gilla,*,‡ Raghupathi Reddy Anumula,‡ Kavitha Charagondla,‡ Prabhakar Reddy Vummenthala,§ and Pratap Reddy Padi
rg. Process Res. Dev. 2012, 16, 9, 1523–1526

Clopidogrel EP Impurity F is chemically Methyl (S)-2-(2-chlorophenyl)-2-((2-(thiophen-2-yl)ethyl)amino)acetate hydrochloride ; S(+)-N-(2-(2-Thienyl)ethyl)-2-chlorophenyl Glycine Methyl Ester Hydrochloride. It is also known as Clopidogrel Thienylethyl Impurity ; Clopidogrel Open Ring Hydrochloride (USP). Clopidogrel EP Impurity F is supplied with detailed characterization data compliant with regulatory guideline. Clopidogrel EP Impurity F 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 Clopidogrel.

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.