Norethindrone Acetate EP Impurity B

Method development and validation of norethindrone acetate assay and its related impurities in API and pharmaceutical formulation with ortogonal detector technques
By Satish, J.; Radhakrishnanand, P.; Babu, K. Surendra
From International Journal of Pharmacy and Pharmaceutical Sciences (2017), 9(12), 110-118
 
Norethindrone acetate (NA) and ethynyl estradiol (EE) related oxidative transformation products in stability samples of formulated drug product: synthesis of authentic references
By Ekhato, I. Victor; Hurley, Tim; Lovdahl, Michael; Revitte, T. J.; Guo, Luyi; Huang, Yun; Clipper, Scott; Colson, Charles
From Steroids (2002), 67(3,4), 165-174

Norethindrone Acetate EP Impurity B is chemically 3-Oxo-19-nor-17α-pregn-5(10)-en-20-yn-17-yl acetate (as per EP). It is also known as Norethindrone Acetate 5,10-Dehydro Impurity ; Norethynodrel Acetate ; Δ-5(10)-Norethindrone Acetate. Norethindrone Acetate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Norethindrone Acetate 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 Norethindrone Acetate.

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.