Description

Medetomidine Impurity CAS NO 1587636-55-2 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 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 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-MS methods to monitor impurity levels.
• Quality Control & Assurance: Employed in routine batch release testing to ensure Medetomidine products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research & Synthesis: Acts as a building block or intermediate for chemical researchers studying the synthesis pathway and metabolism of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity
CAS No.	1587636-55-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound; Medetomidine Specified Impurity; Dexmedetomidine Impurity; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole (specific isomer related to Medetomidine); Precedex Impurity; Medetomidine Process Impurity; Medetomidine Degradant
EINECS	Contact for details

Quality Control

Our Medetomidine Impurity 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 provided with each shipment, detailing the results against predefined specifications. Our quality commitment supports compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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