Amitriptyline EP Impurity B

Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities
Irena Kasagic-Vujanovi , Biljana Janci c-Stojanovi
Journal of Pharmaceutical and Biomedical Analysis 173 (2019) 86–95
 
Chromatographic Methods for the Determination of Fluphenazine, Nortriptyline and Its Impurity Amitriptyline in Bulk and Pharmaceutical Formulations
O. M. ElHoussini and N. H. Zawilla
Journal of Analytical Chemistry, 2014, Vol. 69, No. 12, pp. 1187–1192.
 
Determination of Amitriptyline and its Main Metabolites in Human Plasma Samples using HPLC-DAD: Application to the Determination of Metabolic Ratios after Single Oral Dose of Amitriptyline
Rafael Linden, Marina Venzon Antunes, Ana Luiza Ziulkoski, Maína Wingert, a Paula Tonello, Mladen Tzvetkovb and André Arigony Soutoc
J. Braz. Chem. Soc., Vol. 19, No. 1, 35-41, 2008.

Amitriptyline EP Impurity B is chemically 3-(5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride (as per EP). It is also known as Cyclobenzaprine HCl (EP). Amitriptyline EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Amitriptyline EP Impurity B 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 Amitriptyline.

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.