Description

Medetomidine Impurity 14 CAS NO 79924-14-4 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 veterinary sedative Medetomidine and its related 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 and Identification in Medetomidine API and finished drug products.
• Analytical Method Development and Validation (HPLC, GC, LC-MS) for accurate quantification of related substances.
• Quality Control and Stability Testing to monitor impurity levels throughout the product lifecycle.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA and EMA.
• Research and Development of Medetomidine synthesis pathways and degradation studies.
• Calibration Standard for analytical instrumentation to ensure accurate and reproducible results.
• Reference Material for forensic analysis and pharmacopoeial testing.

Basic Information

Product Name	Medetomidine Impurity 14
CAS No.	79924-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Dexmedetomidine Impurity; Medetomidine Related Compound 14; (S)-Medetomidine Impurity; Precedex Impurity; 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-
EINECS	Contact for details

Quality Control

Our Medetomidine Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment to support your regulatory and research 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 product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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