Description

Medetomidine Impurity 28 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Medetomidine, a key pharmaceutical agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and impurity profiling. The availability of this well-characterized impurity standard is essential for ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Medetomidine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and GC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological profile of Medetomidine-related substances.

Basic Information

Item	Detail
Product Name	Medetomidine Impurity 28
CAS No.	2240179-64-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound 28; Medetomidine Impurity K; Dexmedetomidine Impurity 28; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole (specific isomer); Precedex Impurity; Medetomidine Process Impurity; Medetomidine Degradant
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 28 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure compliance with the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH guidelines and can supply materials suitable for regulatory submissions.

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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.