Description

Dexmedetomidine-021 is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 86347-43-5. This compound is a highly selective α-2 adrenergic receptor agonist, valued for its critical role in the synthesis of advanced active pharmaceutical ingredients (APIs). It is essential for manufacturers and research institutions in the pharmaceutical and biotechnology sectors, particularly those developing sedative, analgesic, and anesthetic formulations.

Application

• Pharmaceutical Synthesis: A key intermediate in the production of Dexmedetomidine hydrochloride, a widely used sedative in intensive care units and procedural sedation.
• Reference Standard: Serves as a certified reference material (CRM) for quality control, method validation, and regulatory compliance in analytical laboratories.
• Research & Development: Used in preclinical and clinical studies to investigate the pharmacology of α-2 adrenoceptors and develop new therapeutic agents.
• Active Pharmaceutical Ingredient (API) Manufacturing: Integral to the synthesis pathway for producing the final bulk API under Good Manufacturing Practice (GMP) conditions.
• Veterinary Medicine: Applied in the development of sedative and analgesic products for animal healthcare.

Basic Information

Product Name	Dexmedetomidine-021
CAS No.	86347-43-5
Molecular Formula	C13H16N2
Molecular Weight	200.28 g/mol
Synonyms	Dexmedetomidine Base; (+)-4-(S)-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Dexmedetomidine Free Base; Dexmedetomidine Impurity; Precedex Intermediate; MPV-1440; BAY-1470
EINECS	Contact for details

Quality Control

Our Dexmedetomidine-021 is manufactured and tested to meet stringent quality standards suitable for pharmaceutical development. We provide comprehensive quality assurance, including batch-specific Certificates of Analysis (COA) with detailed chromatographic purity data, residual solvent analysis, and identification confirmation. Our quality system supports compliance with ICH guidelines and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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