Levonorgestrel EP Impurity A

Comparative study on the application of capillary liquid chromatography and capillary electrochromatography for investigation of enantiomeric purity of the contraceptive drug levonorgestrel
Bezhan Chankvetadze a,b,, Irma Kartozia a , Chiyo Yamamoto c , Yoshio Okamoto c , Gottfried Blaschke
Journal of Pharmaceutical and Biomedical Analysis 30 (2003) 1897/1906
 
Analytical method development and method validation for determination assay and content uniformity of levonorgestrel by reversed-phase highperformance liquid chromatography
vikas kumar pal*, yogendra pal
Asian J Pharm Clin Res, Vol 13, Issue 4, 2020, 101-107

Levonorgestrel EP Impurity A is chemically 13-Ethyl-17-hydroxy-18,19-dinor-17α-pregna-4,8(14)-dien-20-yn-3-one (as per EP). It is also known as Norgestrel 8(14)-Dehydro Impurity. Levonorgestrel EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Levonorgestrel EP Impurity A 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 Levonorgestrel.

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.