Description

Medetomidine Impurity 51 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the veterinary sedative Medetomidine and its pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The availability of this well-characterized impurity standard 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 Medetomidine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release Testing: A critical component in the quality control laboratory for routine analysis of production batches against predefined impurity limits.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Medetomidine Impurity 51
CAS No.	2197018-01-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound 51; Medetomidine Specified Impurity 51; Dexmedetomidine Impurity 51; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole (specific isomer); Medetomidine Degradation Product; Medetomidine Process Impurity; Precedex Impurity 51
EINECS	Contact for details

Quality Control

Our Medetomidine Impurity 51 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. Our quality commitment supports compliance with ICH Q3A/B guidelines and relevant pharmacopeial requirements.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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