Description

Drospirenone Ether Impurity is a high-purity reference standard and process impurity critical for the development and quality control of the active pharmaceutical ingredient (API) drospirenone. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used by researchers and quality control professionals in the pharmaceutical industry for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of drospirenone and its related products.
• Impurity Profiling: Critical for identifying and quantifying this specific process-related impurity during the development and manufacturing of drospirenone API.
• Method Development and Validation: Serves as a key component in developing and validating analytical methods, such as HPLC and LC-MS, for purity assessment.
• Stability Studies: Employed to monitor the formation and levels of this impurity in drug substances and products under various storage conditions.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity control and characterization.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure batch-to-batch consistency and that impurity levels remain within specified limits.

Basic Information

Product Name	Drospirenone Ether Impurity
CAS No.	90376-21-9
Molecular Formula	C24H30O3
Molecular Weight	366.50 g/mol
Synonyms	6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone Ether Impurity; Drospirenone Related Compound; (6β,7β,15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone) Ether Impurity; 17α-(2-Carboxyethyl)-6β,7β;15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-7-carboxylic Acid γ-Lactone Ether Impurity; ZK 30595 Ether Impurity; 90376-21-9; Drospirenone EP Impurity
EINECS	Contact for details

Quality Control

Every batch of Drospirenone Ether Impurity is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We provide full traceability and Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, ensuring compliance with pharmaceutical industry standards. Our quality protocols are designed to meet the rigorous demands of GMP environments and regulatory frameworks such as ICH Q3A/B 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0%

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