Description

Medetomidine Impurity 16 is a high-purity chemical reference standard used in analytical and pharmaceutical development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the veterinary sedative Medetomidine and its related pharmaceutical products. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method validation, stability studies, and impurity profiling. Our supply guarantees the reliability and traceability essential for rigorous quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Medetomidine API and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, calibrating, and validating chromatographic methods to accurately identify and quantify this specific impurity.
• Stability Studies & Forced Degradation: Employed to monitor the formation of Medetomidine Impurity 16 under various stress conditions to establish product shelf-life and storage guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity material for identification and qualification studies.
• Research & Development: Serves as a key intermediate or impurity marker in the synthesis and purification process development of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity 16
CAS No.	75013-50-2
Molecular Formula	C13H16N2
Molecular Weight	200.28 g/mol
Synonyms	1-(2,3-Dimethylphenyl)imidazole; 2,3-Dimethyl-1-(1H-imidazol-1-yl)benzene; Medetomidine Related Compound; Medetomidine Impurity D; Medetomidine EP Impurity D; Dexmedetomidine Impurity 16; Precedex Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 16 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your quality and regulatory needs.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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