Description

Chlormadinone Acetate Impurity I is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in the synthesis and quality assurance of Chlormadinone Acetate API. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC, GC, and other chromatographic analyses.
• Quality Control & Assurance: Used for establishing impurity profiles, setting specification limits, and batch release testing of Chlormadinone Acetate Active Pharmaceutical Ingredient (API).
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Process Chemistry Research: Employed in studying synthetic pathways, optimizing reaction conditions, and identifying by-products during API manufacturing.
• Stability Studies: Used as a marker to monitor the formation of degradation products in drug substance and drug product stability testing programs.

Basic Information

Product Name	Chlormadinone Acetate Impurity I
CAS No.	4203-01-4
Molecular Formula	C23H29ClO4
Molecular Weight	404.93 g/mol
Synonyms	6-Chloro-17α-hydroxypregna-4,6-diene-3,20-dione 17-acetate; 6-Chloro-17α-acetoxypregna-4,6-diene-3,20-dione; 6-Chloropregna-4,6-diene-3,20-dione-17α-ol acetate; Chlormadinone Acetate Related Compound; Chlormadinone Acetate EP Impurity; Chlormadinone Acetate USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Chlormadinone Acetate Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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