Description

Drospirenone Acid Sodium Salt is a key pharmaceutical intermediate in the synthesis of modern progestins. This high-purity compound is critical for ensuring the efficacy and safety of final active pharmaceutical ingredients (APIs). It is primarily utilized by manufacturers in the pharmaceutical and fine chemical industries for the production of hormonal contraceptives and other steroidal medications.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Drospirenone, a progestin used in oral contraceptives and hormone replacement therapies.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a direct precursor in the multi-step synthesis of steroidal APIs under current Good Manufacturing Practice (cGMP) conditions.
• Research & Development: Used in pharmaceutical R&D labs for developing new steroidal drug candidates and studying metabolic pathways.
• Fine Chemical Synthesis: Employed in custom synthesis and process chemistry for creating specialized steroidal derivatives.
• Reference Standard: Can be utilized as a high-purity analytical standard for quality control and method validation in pharmaceutical analysis.

Basic Information

Product Name	Drospirenone Acid Sodium Salt
CAS No.	1393356-37-0
Molecular Formula	C24H29NaO5
Molecular Weight	420.48 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone Sodium Salt; 15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone Sodium Salt; Drospirenone Sodium Salt; Drospirenone-21-carboxylic Acid Sodium Salt; ZK 30595 Sodium Salt; (6β,7β,15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone) Sodium Salt
EINECS	Contact for details

Quality Control

Our Drospirenone Acid Sodium Salt is manufactured under strict quality systems to meet the rigorous standards of the pharmaceutical industry. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant pharmacopeial guidelines and support our clients' regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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