Description

Exemestane Impurity 2 is a designated impurity of the active pharmaceutical ingredient Exemestane, an aromatase inhibitor used in cancer therapy. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for impurity profiling and stability studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Exemestane drug substance and finished products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Item	Detail
Product Name	Exemestane Impurity 2
CAS No.	861395-77-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione Impurity; Exemestane Related Compound 2; 6-Methylideneandrosta-1,4-diene-3,17-dione Impurity; Aromasin Impurity 2; (8R,9S,10R,13S,14S)-6-Methylidene-10,13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydrocyclopenta[a]phenanthrene-3,17-dione; 6-Methyleneandrosta-1,4-diene-3,17-dione Impurity
EINECS	Contact for details

Quality Control

Our Exemestane Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of moisture from the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 5.0%

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