Description

Anastrozole Impurity 19 is a designated pharmaceutical reference standard used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Anastrozole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Anastrozole API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize impurity markers.

Basic Information

Product Name	Anastrozole Impurity 19
CAS No.	1301724-97-9
Molecular Formula	C17H19N5
Molecular Weight	293.37 g/mol
Synonyms	Anastrozole Related Compound 19; 2,2'-[5-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-phenylene]bis(2-methylpropiononitrile); Anastrozole Impurity D; Anastrozole EP Impurity D; Anastrozole Process Impurity; Arimidex Impurity 19; 1,3-Bis(2-cyano-2-propyl)-5-(1H-1,2,4-triazol-1-ylmethyl)benzene
EINECS	Contact for details

Quality Control

Our Anastrozole Impurity 19 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to confirm identity and ensure high purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a pharmaceutical reference standard for compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and desiccated for long-term storage.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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