Description

Medetomidine Impurity 19 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 pharmaceutical substance Medetomidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Medetomidine API (Active Pharmaceutical Ingredient) batches.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to monitor and control the impurity levels in pharmaceutical products, ensuring they meet pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Medetomidine to track the formation of this specific impurity over time and under various stress conditions.
• Research & Development: Utilized in pharmaceutical R&D for studying the degradation pathways, synthesis process optimization, and the toxicological assessment of impurities.

Basic Information

Product Name	Medetomidine Impurity 19
CAS No.	2289714-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole (related structural isomer); Medetomidine Related Compound 19; Medetomidine EP Impurity 19; Medetomidine USP Impurity 19; Dexmedetomidine Impurity 19; Precedex Impurity 19; (RS)-Medetomidine Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, GC, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

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 must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.