Description

Dienogestrel CAS NO 65928-58-7 is a synthetic progestogen belonging to the 19-nortestosterone derivative class, characterized by its high selectivity for the progesterone receptor. This compound is a critical active pharmaceutical ingredient (API) valued for its potent progestogenic activity with minimal androgenic or estrogenic side effects. It is primarily required by pharmaceutical manufacturers for the formulation of hormonal contraceptives and treatments for gynecological disorders such as endometriosis.

Application

• Pharmaceutical API: Primary active ingredient in combined oral contraceptive pills (e.g., in combination with ethinylestradiol).
• Hormone Replacement Therapy (HRT): Used in regimens for managing menopausal symptoms in combination with estrogen.
• Endometriosis Treatment: Key component in therapeutic agents for pain relief and suppression of endometrial tissue growth.
• Dysmenorrhea Management: Utilized in medications to alleviate severe menstrual pain.
• Research & Development: Reference standard and building block in steroid chemistry and pharmacological research.
• Veterinary Pharmaceuticals: Potential use in hormonal treatments for animals.

Basic Information

Product Name	Dienogestrel
CAS No.	65928-58-7
Molecular Formula	C20H25NO2
Molecular Weight	311.42 g/mol
Synonyms	17α-Hydroxy-3-oxo-19-nor-17α-pregna-4,9-diene-21-nitrile; Dienogest; STS 557; 17-Hydroxy-3-oxo-19-nor-17α-pregna-4,9-diene-21-nitrile; 19-Nor-17α-pregna-4,9-diene-17-ol-3,20-dione 21-nitrile; SH D 937 A; ZK 30595; Nomegestrol acetate intermediate (common misnomer)
EINECS	Contact for details

Quality Control

Our Dienogestrel is manufactured under strict quality systems. We offer material compliant with major pharmacopoeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via HPLC, to ensure it meets stringent specifications. A Certificate of Analysis (COA) is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.