Description

Drospirenone/Ethinyl Estradiol CAS NO 164017-31-6 is a synthetic, fixed-dose combination of two steroid hormones used in pharmaceutical formulations. This combination is critical for providing reliable and effective hormonal therapy. It is primarily required by pharmaceutical manufacturers for the production of oral contraceptives and hormone replacement therapies.

Application

• Active Pharmaceutical Ingredient (API) in combined oral contraceptive pills.
• Key component in hormone replacement therapy (HRT) products for managing menopausal symptoms.
• Used in clinical research and development of new hormonal treatments.
• Reference standard in analytical laboratories for quality control and method validation.
• Raw material for the synthesis of more complex steroid-based pharmaceutical compounds.

Basic Information

Product Name	Drospirenone/Ethinyl Estradiol
CAS No.	164017-31-6
Molecular Formula	C24H30O3 • C20H24O2
Molecular Weight	366.50 g/mol (Drospirenone) • 296.41 g/mol (Ethinyl Estradiol)
Synonyms	Drospirenone and Ethinyl Estradiol; DRSP/EE; Yasmin (Brand Name Component); Angeliq (Brand Name Component); 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone / 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol; Ethinylestradiol and Drospirenone; 17α-Ethynyl-1,3,5(10)-estratriene-3,17β-diol with (6β,7β,15β,16β)-3-Oxo-6,7:15,16-bis(methylene)-17-hydroxyandrost-4-en-17-yl propionate.
EINECS	Contact for details

Quality Control

Our Drospirenone/Ethinyl Estradiol is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use, with specifications aligned with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) documenting identity, purity, and related substances is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (for each component)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF)	NMT 2.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

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