Description

Exemestane Impurity B -F is a designated impurity standard used in the analytical profiling of the active pharmaceutical ingredient, Exemestane. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Exemestane API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating analytical methods as per ICH guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Development: Used in R&D to understand the degradation pathways and impurity profile of Exemestane during synthesis and formulation.

Basic Information

Product Name	Exemestane Impurity B -F
CAS No.	184972-09-6
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 (Exemestane Impurity B); Exemestane Related Compound B; 17β-Hydroxy-6-methylideneandrosta-1,4-dien-3-one; Aromasin Impurity B; 6-Methyleneandrosta-1,4-diene-3,17-dione
EINECS	Contact for details

Quality Control

Our Exemestane Impurity B -F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using validated methods, including HPLC for assay and related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and chromatographic data.

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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.