Description

Exemestane Related Compound CAS NO 881896-95-3 is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard in the quality control of Exemestane, a potent aromatase inhibitor used in cancer therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and ensuring batch-to-batch consistency of the active pharmaceutical ingredient (API).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control specific impurities in Exemestane API during manufacturing.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to ensure accurate impurity detection.
• Quality Assurance & Control (QA/QC): Employed in routine batch release testing to confirm the purity and specification compliance of Exemestane drug substances and products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and qualification data.
• Stability Studies: Used to monitor the formation of degradation products in Exemestane formulations under various stress conditions (heat, light, humidity).
• Research & Development: Supports synthetic chemistry research for process optimization and the development of new synthetic routes for steroidal compounds.

Basic Information

Product Name	Exemestane Related Compound CAS NO 881896-95-3
CAS No.	881896-95-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione related compound; Exemestane Impurity; Exemestane Specified Impurity; Aromasin Impurity; Steroidal aromatase inhibitor related substance; Androsta-1,4-diene-3,17-dione, 6-methylidene-, related compound
EINECS	Contact for details

Quality Control

Our Exemestane Related Compound is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, identity, and all relevant analytical data to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain optimal stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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