Description

Megestrol Acetate Ep Impurity E is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Megestrol Acetate. This compound is critical for pharmaceutical quality control, enabling manufacturers to monitor, identify, and quantify impurities to ensure drug safety and efficacy. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) involved in the development and production of hormone-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Impurity E in Megestrol Acetate drug substance and finished products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, for impurity profiling.
• Quality Control and Batch Release: Essential for routine quality control testing to ensure batches of Megestrol Acetate comply with pharmacopoeial limits for specified impurities as per EP, USP, or ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in stability testing of pharmaceutical formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Megestrol Acetate Ep Impurity E
CAS No.	982-89-8
Molecular Formula	C24H32O4
Molecular Weight	384.51 g/mol
Synonyms	6-Methyl-3,20-dioxopregna-4,6-dien-17-yl acetate; 6-Methyl-6-dehydro-17α-acetoxyprogesterone; 6-Methyl-6-dehydro-17α-hydroxyprogesterone acetate; 6-Methyl-δ6-17α-acetoxyprogesterone; Megestrol Acetate Impurity E; Megestrol Acetate Related Compound E; EP Impurity E of Megestrol Acetate; USP Related Compound E
EINECS	Contact for details

Quality Control

Our Megestrol Acetate Ep Impurity E is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of related substances, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, 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 product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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