Description

Megestrol Acetate EP Impurity C is a specified impurity of the active pharmaceutical ingredient Megestrol Acetate, a synthetic progestin. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Megestrol Acetate drug products and formulations.

Application

• Primary use as a pharmaceutical reference standard for Megestrol Acetate impurity profiling.
• Critical component in analytical method development and validation (HPLC, LC-MS) for quality control laboratories.
• Used in stability studies and forced degradation studies to identify and quantify degradation products.
• Essential for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control.
• Serves as a system suitability standard in chromatographic assays for Megestrol Acetate raw materials and finished dosage forms.
• Supports research and development of Megestrol Acetate-based therapies, including oncology and hormonal treatments.

Basic Information

Product Name	Megestrol Acetate EP Impurity C
CAS No.	74910-22-8
Molecular Formula	C₂₄H₃₂O₄
Molecular Weight	384.51 g/mol
Synonyms	6-Methyl-3,20-dioxopregna-4,6-dien-17-yl acetate; 6-Methyl-17α-acetoxy-6-dehydroprogesterone; Megestrol Acetate Impurity C; Megestrol Acetate Related Compound C; 6-Dehydro-6-methyl-17α-acetoxyprogesterone; 17α-Acetoxy-6-methyl-6-dehydroprogesterone; Megestrol Acetate EP Impurity C (EP); Megestrol Acetate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Megestrol Acetate EP Impurity C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR), to ensure compliance with pharmacopeial standards such as the European Pharmacopoeia (EP). A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment to support your regulatory and quality assurance needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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