Norethindrone EP Impurity C

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
 
Reversed-​phase high-​performance liquid chromatographic determination of Norethindrone acetate and ethinyl estradiol in pharmaceutical formulation
By Koneru, Ajitha; Kimbahune, Ritu; Mubeen, G.; Lalitha, N.; Chakraborty, Krishnasis
From Indo American Journal of Pharmaceutical Research (2015), 5(6), 2442-2449
 
Development and validation of method for the determination of related substances of norethindrone in norethindrone tablets and degradation studies
By Murali Krishna, P.; Thirupathi Rao, B.; Kishore Kumar, R.; Venkateswarlu, P.
From International Journal of ChemTech Research (2011), 3(1), 143-148

Norethindrone EP Impurity C is chemically 17-hydroxy-19-nor-17α-pregn-5-en-20-yn-3-one (as per EP). It is also known as Norethindrone 5,6-Dehydro Impurity. Norethindrone EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Norethindrone 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 Norethindrone.

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.