Description

Exemestane Impurity 1 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 reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Exemestane drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Exemestane active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Exemestane API and drug products meet stringent pharmacopeial (USP, EP, ICH) specifications for impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Exemestane formulations.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Exemestane under various environmental conditions.

Basic Information

Item	Details
Product Name	Exemestane Impurity 1
CAS No.	159354-61-7
Molecular Formula	C20H24O2
Molecular Weight	296.40 g/mol
Synonyms	6-Methylenandrosta-1,4-diene-3,17-dione; 6-Methylenandrosta-1,4-diene-3,17-dione (Exemestane Impurity); 6-Methylideneandrosta-1,4-diene-3,17-dione; 6-Methyleneandrosta-1,4-diene-3,17-dione; Androsta-1,4-diene-3,17-dione, 6-methylidene-; Exemestane Related Compound A; Exemestane Impurity A; Aromasin Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Exemestane Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with ICH Q3A, Q3B, USP, and EP guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
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.