Description

Anastrozole Impurity (3-(1-Cyano-1-Methylethyl)-Alfa,Alfa-Dimethyl-5-(1H-,1,2,4-Triazole-1-Ylmethyl)-Benzeneacetic Acid) is a critical pharmaceutical reference standard used for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Anastrozole, a widely used aromatase inhibitor. It serves as a key impurity standard for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and quality control. The product is supplied with a high level of purity and traceability to support rigorous compliance standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Anastrozole API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products during stability studies, ensuring drug product shelf-life and safety.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development (R&D): Used in synthetic chemistry R&D to understand impurity formation pathways and to develop robust purification processes for the API.
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant for routine batch release testing of Anastrozole.

Basic Information

Product Name	Anastrozole Impurity (3-(1-Cyano-1-Methylethyl)-Alfa,Alfa-Dimethyl-5-(1H-,1,2,4-Triazole-1-Ylmethyl)-Benzeneacetic Acid)
CAS No.	1338800-82-0
Molecular Formula	C17H20N4O2
Molecular Weight	312.37 g/mol
Synonyms	3-(1-Cyano-1-methylethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)benzeneacetic acid; Anastrozole Related Compound; Anastrozole Impurity A (potential designation); 2-[3-(2-Cyano-2-propanyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)phenyl]acetic acid; Arimidex Impurity; Benzeneacetic acid, 3-(1-cyano-1-methylethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-; Anastrozole Process Impurity; Anastrozole Degradant
EINECS	Contact for details

Quality Control

Our Anastrozole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. Our quality protocols are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

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 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.