Description

Anastrozole Impurity (Alfa1 , Alfa1, Alfa3, Alfa3-Tetramethyl-5-(1H-1,2,4-Triazol-1-Ylmethyl)-1,3-Benzenediacetic Acid) is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Anastrozole. This compound serves as a key impurity marker, essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the development and manufacturing of aromatase inhibitor therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Anastrozole API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Enables precise monitoring and control of impurity levels during API synthesis and drug manufacturing to meet ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific degradation product.
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Anastrozole Impurity (Alfa1 , Alfa1, Alfa3, Alfa3-Tetramethyl-5-(1H-1,2,4-Triazol-1-Ylmethyl)-1,3-Benzenediacetic Acid)
CAS No.	1338800-81-9
Molecular Formula	C20H24N4O4
Molecular Weight	384.43 g/mol
Synonyms	Anastrozole Related Compound A; 2,2'-(5-((1H-1,2,4-Triazol-1-yl)methyl)-1,3-phenylene)bis(2-methylpropanoic Acid); α,α,α',α'-Tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetic Acid; Anastrozole Impurity A; Anastrozole EP Impurity A; Anastrozole USP Related Compound A; ZD1033 Impurity
EINECS	Contact for details

Quality Control

Our Anastrozole Impurity standard is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC, MS, NMR, and IR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with batch-specific data, ensuring traceability and compliance with 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) in a dry environment. The product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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