Description

Atipamezole Impurity CAS NO 104054-24-2 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Atipamezole, a veterinary pharmaceutical agent. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety and efficacy. The impurity standard is essential for method validation, stability studies, and meeting stringent regulatory requirements for veterinary drug submissions.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Atipamezole drug substance and finished products.
• Analytical Method Development & Validation (HPLC/GC): Used as a known impurity to develop, optimize, and validate chromatographic methods for purity testing.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and monitor degradation pathways of Atipamezole.
• Quality Control & Batch Release: A critical component in the QC laboratory for routine testing of active pharmaceutical ingredients (APIs) to ensure compliance with specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing necessary data on impurity profiles.
• Research & Development: Used in synthetic chemistry R&D to understand and control the formation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Atipamezole Impurity
CAS No.	104054-24-2
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 Impurity A; Atipamezole EP Impurity; Antisedan Impurity; 1H-Indene-5-carbonitrile, 4-(2-ethyl-1H-imidazol-1-yl)-2,3-dihydro-; 104054-24-2
EINECS	Contact for details

Quality Control

Every batch of Atipamezole Impurity (CAS 104054-24-2) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Our quality system is designed to meet the needs of the pharmaceutical industry, with testing typically including HPLC for assay and related substances, IR for identification, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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