Description

Medetomidine Impurity 42 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 veterinary sedative Medetomidine and its pharmaceutical formulations. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Medetomidine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance: Essential for routine batch release testing in QC laboratories to ensure Medetomidine products meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products and establish shelf-life for Medetomidine formulations.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in academic and industrial research to study the metabolism, degradation pathways, and synthesis-related impurities of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity 42
CAS No.	189255-79-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Medetomidine Related Compound 42; Medetomidine EP Impurity B; Medetomidine USP Impurity; Dexmedetomidine Impurity 42; Precedex Impurity 42; (RS)-4-[1-(2,3-Dimethylphenyl)ethyl]imidazole
EINECS	Contact for details

Quality Control

Our Medetomidine Impurity 42 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results for purity, related substances, and residual solvents. Our quality standards align with ICH guidelines to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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