Description

Exemestane Impurity 13 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Exemestane. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of aromatase inhibitor drugs.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Exemestane API.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control.
• Essential for regulatory compliance and submission to agencies like the FDA, EMA, and other global health authorities.
• Used in stability studies to monitor impurity profiles and degradation pathways of Exemestane under various conditions.
• Supports pharmaceutical research into the synthesis, metabolism, and degradation chemistry of steroidal compounds.
• Employed by contract research organizations (CROs) and quality control laboratories for batch release testing.

Basic Information

Product Name	Exemestane Impurity 13
CAS No.	152764-29-9
Molecular Formula	C20H24O2
Molecular Weight	296.41 g/mol
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione; 6-Methylenandrosta-1,4-diene-3,17-dione impurity; Exemestane Related Compound 13; Androsta-1,4-diene-3,17-dione, 6-methylene-; 6-Methyleneandrosta-1,4-diene-3,17-dione; Aromasin Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Exemestane Impurity 13 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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