Description

3β,5β-Dihydroxy Drospirenone Ring-Opened Alcohol Impurity is a key process-related impurity and degradation product of the active pharmaceutical ingredient Drospirenone. This compound is critical for pharmaceutical manufacturers and analytical laboratories focused on quality control and regulatory compliance during the synthesis and formulation of hormonal contraceptives and other therapeutic agents. It serves as an essential reference standard for method development, validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Drospirenone API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and third-party testing labs to monitor batch-to-batch consistency and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	3β,5β-Dihydroxy Drospirenone Ring-Opened Alcohol Impurity
CAS No.	82543-18-8
Molecular Formula	C24H30O4
Molecular Weight	382.50 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone Ring-Opened Alcohol; (8R,9S,10R,13S,14S,15R,16R,17R)-17-(2-Hydroxyacetyl)-13-methyl-2,8,9,10,11,12,13,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-3,15,16-triol; Drospirenone Impurity F; Drospirenone Ring-Opened Alcohol; Drospirenone Related Compound F; 3β,5β-Dihydroxy Drospirenone; 17α-(2-Hydroxyethyl)-6β,7β;15β,16β-bis(methylene)-17β-hydroxy-3-oxoandrost-4-ene
EINECS	Contact for details

Quality Control

Our 3β,5β-Dihydroxy Drospirenone Ring-Opened Alcohol Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and GMP guidelines.

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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.