Description

17R-Drospirenone is a high-purity, non-androgenic progestin compound of significant pharmaceutical importance. Its unique pharmacological profile makes it a critical active pharmaceutical ingredient (API) for the development of modern hormonal therapies. This compound is essential for manufacturers in the global pharmaceutical industry, particularly for the production of oral contraceptives and treatments for hormone-related conditions.

Application

• Primary Active Pharmaceutical Ingredient (API) in oral contraceptive formulations.
• Key component in hormone replacement therapy (HRT) products for menopausal symptom management.
• Utilized in the treatment of premenstrual dysphoric disorder (PMDD).
• Research and development of novel progestin-based therapeutic agents.
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Starting material for the synthesis of related steroidal drug substances.

Basic Information

Product Name	17R-Drospirenone
CAS No.	90457-65-1
Molecular Formula	C24H30O3
Molecular Weight	366.50 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Drospirenone (17R-isomer); 17α-Drospirenone; 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregna-4-ene-21,17-carbolactone; ZK 30595; SC 10363; 17R-Drospirenone API
EINECS	Contact for details

Quality Control

Our 17R-Drospirenone is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical actives. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with agreed specifications. We support customer audits and can provide documentation relevant to cGMP, ICH guidelines, and major pharmacopoeial standards.

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. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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