Description

Atipamezole Impurity CAS NO 1160219-71-5 is a high-purity chemical reference standard used in the analytical characterization and quality control of the veterinary pharmaceutical Atipamezole. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in veterinary drug development and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities in Atipamezole drug substance and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Stability Studies: Aids in monitoring the formation of degradation products in Atipamezole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and tracking impurity formation during manufacturing.

Basic Information

Product Name	Atipamezole Impurity
CAS No.	1160219-71-5
Molecular Formula	C14H16N2S
Molecular Weight	244.36 g/mol
Synonyms	4-(2-Ethyl-1H-imidazol-1-yl)-2,3-dihydro-1H-indene-5-carbonitrile; Atipamezole Related Compound; Atipamezole Process Impurity; Antisedan Impurity; MPV-1240 Impurity; Dexmedetomidine Antagonist Impurity; (RS)-4-(2-Ethyl-1H-imidazol-1-yl)-2,3-dihydroinden-5-carbonitrile
EINECS	Contact for details

Quality Control

Our Atipamezole Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS), to ensure identity, strength, quality, and purity. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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