Description

Medetomidine Impurity 3 is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the veterinary sedative Medetomidine. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies to ensure product purity, safety, and efficacy through precise analytical methods.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Medetomidine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Medetomidine formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Medetomidine.

Basic Information

Product Name	Medetomidine Impurity 3
CAS No.	104245-83-2
Molecular Formula	C13H16N2
Molecular Weight	200.28 g/mol
Synonyms	4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Dexmedetomidine Impurity C; Medetomidine Related Compound C; (S)-Medetomidine Impurity 3; (R)-Medetomidine Impurity 3; Precedex Impurity; MPV-1440 Impurity
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, related substances, and residual solvents, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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