Description

Medetomidine Impurity 30 is a high-purity 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 products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Medetomidine API (Active Pharmaceutical Ingredient).
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity formation.
• Used in pharmaceutical research to understand the degradation pathways and metabolism of Medetomidine.
• Serves as a key material for regulatory submissions (e.g., for FDA, EMA) requiring detailed impurity characterization.
• Supports GMP (Good Manufacturing Practice) compliance by providing a traceable standard for impurity control.

Basic Information

Product Name	Medetomidine Impurity 30
CAS No.	172498-90-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound 30; Medetomidine EP Impurity D; Dexmedetomidine Impurity 30; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; (S)-Medetomidine Impurity 30; (R)-Medetomidine Impurity 30; Precedex Impurity 30
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 30 is manufactured and tested under strict quality systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability meet the exacting standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.