Description

Medetomidine Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the veterinary sedative Medetomidine. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in impurity profiling, method development, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Medetomidine and related pharmaceutical products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and calibrating chromatographic methods to accurately identify and quantify this specific impurity.
• Impurity Profiling & Characterization: Used in stability studies and forced degradation studies to understand the degradation pathways of Medetomidine and establish impurity limits.
• Quality Assurance & Control (QA/QC): A critical tool for in-process testing and final product release to ensure batches meet stringent pharmacopeial or internal specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and supporting the establishment of acceptable limits.
• Research & Development: Used in synthetic chemistry R&D to study the formation and mitigation of this impurity during the manufacturing process of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity 18
CAS No.	2289714-15-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound 18; Medetomidine Impurity; Dexmedetomidine Impurity 18; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole (specific isomer); Medetomidine Degradation Product; Medetomidine Process Impurity; (R)-Medetomidine Impurity; Pharmaceutical Impurity Standard 2289714-15-2
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with research and pharmaceutical standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH 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.