Diltiazem EP Impurity F (HCl salt)

Identification of Diltiazem Impurities/Artifacts during the Analyses of Illicit Cocaine Exhibits Containing Diltiazem
John F. Casale,1,* Pauline M. Orlando,2 Valerie L. Colley,1 and Patrick A. Hays
Microgram Journal, Volume 6, Numbers 3-4 (July - December, 2008)
 
Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation
Vivekanand A. ChatpalliwarPawan K. PorwalNeeraj Upmanyu
Journal of Pharmaceutical Analysis Volume 2, Issue 3, June 2012, Pages 226-237
 
Analytical Characterization of two new related impurities of Diltiazem by High Resolution Mass spectrometry and NMR techniques
Jagadeesh narkedimilli, y. ravindrakumar1 , sandeep mohanty1 ,t. srinivasarao1 and a. jayashree
oriental journal of chemistry vol. 31, No. (3): Pg. 1801-1809.

Diltiazem EP Impurity F (HCl salt) is chemically (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one hydrochloride (as per EP) ; 5-[2-(Dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydrobenzo[b][1,4]thiazepin4(5H)-one hydrochloride (as per USP). It is also known as Desacetyl Diltiazem Hydrochloride (USP). Diltiazem EP Impurity F (HCl salt) is supplied with detailed characterization data compliant with regulatory guideline. Diltiazem EP Impurity F (HCl salt) 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 Diltiazem.

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.