Description

Exemestane Ep Impurity C is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of impurities during the manufacturing and quality assurance of Exemestane, an important active pharmaceutical ingredient (API). It is primarily used by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Exemestane API and finished drug products.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for impurity profiling, stability indicating assays, and forced degradation studies.
• Regulatory Compliance: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry: Employed in the optimization and monitoring of Exemestane synthesis to identify and minimize the formation of this specific impurity.
• Academic & Contract Research: Utilized in universities and CROs for pharmacokinetic, metabolic, and toxicological studies related to Exemestane.

Basic Information

Product Name	Exemestane Ep Impurity C
CAS No.	2130745-60-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione Impurity C; Exemestane Related Compound C; Androsta-1,4,6-triene-3,17-dione, 6-methyl-; Exemestane EP Impurity C; Exemestane Impurity C (EP); Aromasin Impurity C
EINECS	Contact for details

Quality Control

Our Exemestane Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality needs.

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 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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