Description

Anastrozole Ep Impurity I is a specified impurity associated with the active pharmaceutical ingredient Anastrozole, a non-steroidal aromatase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control testing. It is essential for ensuring the purity, safety, and efficacy of Anastrozole drug substances and finished products. This impurity is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance with pharmacopeial standards.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Anastrozole API and formulations.
• Critical for Analytical Method Development and Validation (HPLC, GC, LC-MS) in quality control laboratories.
• Essential material for Stability Studies and forced degradation studies to understand impurity profiles.
• Used in Regulatory Submissions to support drug master files (DMFs) and new drug applications (NDAs).
• Supports Pharmacopeial Testing to meet stringent EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH guidelines.
• Valuable for Research and Development in synthetic chemistry and impurity synthesis pathways.

Basic Information

Item	Detail
Product Name	Anastrozole Ep Impurity I
CAS No.	120511-91-3
Molecular Formula	C17H19N5
Molecular Weight	293.37 g/mol
Synonyms	Anastrozole Impurity I; Anastrozole Related Compound I; 2,2'-[5-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-phenylene]bis(2-methylpropiononitrile); Arimidex Impurity I; 1,3-Bis(2-cyano-2-propyl)-5-((1H-1,2,4-triazol-1-yl)methyl)benzene; ZD1033 Impurity I
EINECS	Contact for details

Quality Control

Every batch of Anastrozole Ep Impurity I is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request to support your regulatory and quality assurance needs.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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 individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% 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.