Description

Exemestane Impurity 11 is a designated impurity of the active pharmaceutical ingredient Exemestane, an aromatase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on ensuring the purity, safety, and efficacy of Exemestane-based drug products.

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 & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Exemestane APIs and formulations meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions during drug product shelf-life studies.
• Research & Development: Aids in studying the degradation pathways and chemical behavior of Exemestane during synthesis and formulation processes.

Basic Information

Product Name	Exemestane Impurity 11
CAS No.	107868-36-0
Molecular Formula	C20H24O2
Molecular Weight	296.40 g/mol
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione; 6-Methyleneandrosta-1,4-diene-3,17-dione; 17β-Hydroxy-6-methylenandrosta-1,4-dien-3-one; Exemestane Related Compound; Aromasin Impurity
EINECS	Contact for details

Quality Control

Our Exemestane Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide full traceability and Certificates of Analysis (COA) detailing all test results, ensuring compliance with the high standards required for pharmaceutical reference materials.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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