Description

Medroxyprogesterone Acetate Impurity 3 is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Medroxyprogesterone Acetate, a widely used synthetic progestin. It serves as a vital tool for researchers and quality assurance professionals in the pharmaceutical industry, ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Medroxyprogesterone Acetate Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity analysis.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Compliance and Documentation: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Quality Control Laboratories: Used as a system suitability standard and for routine batch release testing in QC labs to ensure product specifications are met.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Medroxyprogesterone Acetate Impurity 3
CAS No.	113891-99-9
Molecular Formula	C24H34O4
Molecular Weight	386.53 g/mol
Synonyms	6-Methyl-3,20-dioxopregna-4,6-dien-17-yl acetate; 6-Methyl-17α-acetoxy-6-dehydroprogesterone; 6-Methyl-6-dehydro-17α-acetoxyprogesterone; 6-Methyl-δ6-17α-acetoxyprogesterone; Medroxyprogesterone Acetate Related Compound C; Medroxyprogesterone Acetate EP Impurity C; Medroxyprogesterone Acetate USP Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Medroxyprogesterone Acetate Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques including HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white 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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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