Description

Exemestane Related Compound B (15 Mg) (6-Hydroxymethylandrostra-1,4-Diene-3,17-Dione) is a high-purity reference standard and pharmaceutical intermediate. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Exemestane through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, quality control, and regulatory compliance. The availability of this well-characterized related substance is essential for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Exemestane API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and GC methods to monitor process-related impurities and degradation products.
• Quality Control & Assurance (QC/QA): A critical component in the routine batch release testing of Exemestane to ensure it meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of specific degradation impurities under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides necessary impurity data and characterization reports required for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process optimization for steroidal compounds.

Basic Information

Product Name	Exemestane Related Compound B (15 Mg) (6-Hydroxymethylandrostra-1,4-Diene-3,17-Dione)
CAS No.	121021-51-0
Molecular Formula	C20H26O3
Molecular Weight	314.42 g/mol
Synonyms	6-Hydroxymethylandrosta-1,4-diene-3,17-dione; 6-(Hydroxymethyl)androsta-1,4-diene-3,17-dione; Exemestane Impurity B; Exemestane Related Substance B; 6-Hydroxymethyl Exemestane; Aromasin Related Compound B; Androsta-1,4-diene-3,17-dione, 6-(hydroxymethyl)-; FCE 24304 Related Compound
EINECS	Contact for details

Quality Control

Our Exemestane Related Compound B is manufactured under strict quality systems and undergoes comprehensive analytical testing. Each batch is characterized using advanced techniques including HPLC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each unit, which includes batch-specific data on purity, related substances, and residual solvents, ensuring compliance with ICH Q3A and Q3B guidelines for pharmaceutical impurities. Our quality commitment supports your regulatory requirements for reference standards.

Storage

Preserve in the original, 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); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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