Description

Drospirenone Lactol Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of drospirenone, a synthetic progestin. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) by serving as a marker for specific synthetic pathways or degradation products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling. The compound is identified by the CAS number 863329-71-9.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor the lactol-related impurity in drospirenone API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to ensure accurate impurity detection.
• Stability Studies & Forced Degradation: Employed in stability-indicating assays to understand the degradation pathways of drospirenone under various stress conditions.
• Quality Control (QC) & Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global regulatory requirements.
• Research & Development (R&D): Used in synthetic chemistry research to study reaction mechanisms and optimize processes to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Drospirenone Lactol Impurity
CAS No.	863329-71-9
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 Lactol; Drospirenone Related Compound; (6β,7β,15β,16β)-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 17α-(2-Carboxyethyl)-6β,7β;15β,16β-dimethylene-3-oxo-17α-pregn-4-en-21-oic acid γ-lactone (lactol form); Drospirenone Impurity (Lactol); ZK 30595 Lactol Impurity
EINECS	Contact for details

Quality Control

Our Drospirenone Lactol Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing all test results and confirming compliance with relevant specifications.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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