Description

5-Hydroxy Drospirenone Lactol Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of drospirenone-based active pharmaceutical ingredients (APIs). This compound is critical for ensuring the purity, safety, and efficacy of final drug products by serving as a marker for specific synthetic pathways and degradation profiles. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in drospirenone API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor process-related impurities.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of drospirenone under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Used by R&D chemists to optimize synthesis routes and minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	5-Hydroxy Drospirenone Lactol Impurity
CAS No.	863329-70-8
Molecular Formula	C24H30O5
Molecular Weight	398.49 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone 5-Hydroxy Derivative; Drospirenone 5-Hydroxy Lactol Impurity; 5-Hydroxy Drospirenone Lactol; 17-Hydroxy-6β,7β;15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21-carboxylic Acid γ-Lactone 5-ol; Related Compound A of Drospirenone; Drospirenone EP Impurity F; Drospirenone USP Related Compound A
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Drospirenone Lactol Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (by HPLC)	≥ 95.0%
Related Substances (by HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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