Description

Anastrozole Impurity (3-(1-Cyano-1-Methylethyl)-Alfa,Alfa-Dimethyl-5-(1H-,1,2,4-Triazole-1-Ylmethyl)-Benzeneacetamide) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the quality control and regulatory compliance of Anastrozole, a widely used aromatase inhibitor. It is essential for analytical method development, validation, and stability studies to ensure drug safety and efficacy. Pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories rely on this impurity standard to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Anastrozole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during drug manufacturing.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC labs to ensure the accuracy and precision of impurity assays for batch release.
• Research & Process Chemistry: Used by synthetic chemists to study the formation pathway of this impurity and optimize synthesis processes to minimize its presence.

Basic Information

Product Name	Anastrozole Impurity (3-(1-Cyano-1-Methylethyl)-Alfa,Alfa-Dimethyl-5-(1H-,1,2,4-Triazole-1-Ylmethyl)-Benzeneacetamide)
CAS No.	120512-03-0
Molecular Formula	C17H21N5O
Molecular Weight	311.39 g/mol
Synonyms	3-(1-Cyano-1-methylethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)benzeneacetamide; Anastrozole Related Compound; Anastrozole Impurity A (common designation); 2,2'-[5-[(1H-1,2,4-Triazol-1-yl)methyl]-1,3-phenylene]bis(2-methylpropionitrile) derivative; Arimidex Impurity; Benzeneacetamide, 3-(1-cyano-1-methylethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-; ZD1033 Impurity
EINECS	Contact for details

Quality Control

Our Anastrozole Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. We provide detailed Certificates of Analysis (COA) with each shipment, which include batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.