Description

Medetomidine Impurity 34 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 pharmaceutical agent Medetomidine and its formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The use 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 API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity 34
CAS No.	86347-44-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Medetomidine Related Compound 34; Dexmedetomidine Impurity 34; Medetomidine EP Impurity G; Medetomidine USP Impurity; Precedex Impurity; MPV-1440 Impurity
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 34 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere after each use.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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