Mexiletine Hydrochloride EP Impurity C

High-performance liquid chromatographic determination of mexiletine in film-coated tablets using a new polymeric stationary phase
E. Lamparter
Journal of Chromatography, 635 (1993) 155-159
 
Selective and Stability-Indicating Methods for the Simultaneous Determination of Mexiletine Hydrochloride and/or Its Related Substance: 2,6-Dimethylphenol
tarek s. belal, rim s. haggag, and rasha a. shaalan
Journal of AOAC International 91(4):720-30
 
Development and application of a validated HPLC method for the analysis of dissolution samples of mexiletine hydrochloride capsules
dragan m. milenović1 and zoran b.todorović
J. Serb. Chem. Soc. 75 (7) 975–985 (2010)
 
Stereoselective binding of mexiletine and ketoprofen enantiomers with human serum albumin domains
Da Shi, Yin-xiu Jin, Yi-hong Tang, Hai-hong Hu, Si-yun Xu, Lu-shan Yu, Hui-di Jiang & Su Zeng
Acta Pharmacologica Sinica volume 33, pages710–716(2012)

Mexiletine Hydrochloride EP Impurity C is chemically 1,1'-((3,3',5,5'-tetramethyl-[1,1'-biphenyl]-4,4'-diyl)bis(oxy))bis(propan-2-amine) dihydrochloride. Mexiletine Hydrochloride EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Mexiletine Hydrochloride EP Impurity C 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 Mexiletine.

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.