Description

Anastrozole Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Anastrozole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The use of well-characterized impurities like this is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Anastrozole API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and calibrating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Stability Studies: Employed to track the formation and levels of this specific degradant during forced degradation and long-term stability testing of Anastrozole formulations.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies as per ICH guidelines.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Anastrozole and related compounds.

Basic Information

Product Name	Anastrozole Impurity 18
CAS No.	1186102-55-5
Molecular Formula	C17H19N5
Molecular Weight	293.37 g/mol
Synonyms	Anastrozole Related Compound 18; 2,2'-[5-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile); Anastrozole Degradant 18; Anastrozole Process Impurity 18; Arimidex Impurity 18; 1,3-Bis(2-cyano-2-propyl)-5-((1H-1,2,4-triazol-1-yl)methyl)benzene
EINECS	Contact for details

Quality Control

Every batch of Anastrozole Impurity 18 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.