Description

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 enabling accurate identification and quantification of related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments involved in the production of hormonal contraceptives and other steroidal medications.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying the Drospirenone Lactol impurity in bulk APIs and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for quality control protocols.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submission and Compliance: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Process Chemistry Optimization: Used by R&D and manufacturing teams to trace and minimize the formation of this impurity during the synthesis and purification stages of drospirenone production.
• Quality Assurance/Quality Control (QA/QC) Testing: A vital component in routine batch release testing to ensure that impurity levels remain within specified safety thresholds.

Basic Information

Product Name	Drospirenone Lactol Impurity
CAS No.	52520-27-1
Molecular Formula	C24H30O3
Molecular Weight	366.50 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; (6β,7β,15β,16β)-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Drospirenone Lactol; Drospirenone Related Compound; 17α-(2-Carboxyethyl)-6β,7β;15β,16β-bis(methylene)-3-oxoandrost-4-en-17β-ol Lactone
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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