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Gestodene EP Impurity J is chemically 13-Ethylspiro(18,19-dinor-17α-pregna-5,15-dien-20-yne-3,2′-[1,3]dioxolan)-17-ol and 13-ethylspiro(18,19-dinor-17α-pregna-5(10),15-dien-20-yne-3,2′-[1,3]dioxolan)-17-ol (as per EP).
It is also known as Gestodene Ketal.
Gestodene EP Impurity J is supplied with detailed characterization data compliant with regulatory guideline. Gestodene EP Impurity J 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 Gestodene.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.