Description

Anastrozole Impurity (Alfa1 , Alfa1, Alfa3, Alfa3-Tetramethyl-5-(1H-1,2,4-Triazol-1-Ylmethyl)-1,3-Benzenediacetamide) is a structurally defined impurity and reference standard critical for the quality control of the active pharmaceutical ingredient (API) Anastrozole. This compound is essential for pharmaceutical manufacturers to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used by pharmaceutical R&D laboratories, quality control (QC) departments, and analytical service providers involved in the development and production of aromatase inhibitor drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Anastrozole API and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Critical for routine QC testing to monitor impurity levels and ensure every batch of Anastrozole meets stringent pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Anastrozole, supporting improved formulation and packaging strategies.

Basic Information

Item	Details
Product Name	Anastrozole Impurity (Alfa1 , Alfa1, Alfa3, Alfa3-Tetramethyl-5-(1H-1,2,4-Triazol-1-Ylmethyl)-1,3-Benzenediacetamide)
CAS No.	120512-04-1
Molecular Formula	C20H26N6O2
Molecular Weight	382.47 g/mol
Synonyms	Anastrozole Impurity A; Anastrozole Related Compound A; 2,2'-[5-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-phenylene]bis(2-methylpropionamide); α,α,α',α'-Tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetamide; 1,3-Bis(2-methyl-2-aminocarbonylpropyl)-5-(1,2,4-triazol-1-ylmethyl)benzene; Arimidex Impurity A; ICI D1033 Impurity
EINECS	Contact for details

Quality Control

Every batch of this Anastrozole Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a high-purity reference standard. Identity, purity, and impurity content are confirmed using advanced techniques including HPLC, GC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each product, providing batch-specific results. Our quality systems are designed to support compliance with cGMP, ICH guidelines, and relevant pharmacopeial standards (USP, EP).

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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