Description

Dexmedetomidine Hydrochloride is a highly selective α-2 adrenergic receptor agonist, widely recognized for its potent sedative and analgesic properties. This pharmaceutical active ingredient is critical for its ability to provide procedural sedation without significant respiratory depression. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development of injectable sedative and anesthetic formulations. The compound is supplied to meet the stringent quality requirements of the global pharmaceutical industry.

Application

• Pharmaceutical Manufacturing: Primary active ingredient in injectable sedative solutions (e.g., Precedex®).
• Critical Care Medicine: Used for sedation of initially intubated and mechanically ventilated patients in intensive care settings.
• Procedural Sedation: Key component in formulations for non-painful diagnostic procedures and pre-operative sedation.
• Veterinary Medicine: Employed in sedative and analgesic protocols for companion and large animals.
• Analgesic Adjunct: Used as part of balanced anesthesia to reduce opioid requirements during surgery.
• Research & Development: Reference standard and building block in neurological and pharmacological research targeting α-2 receptors.

Basic Information

Product Name	Dexmedetomidine Hydrochloride
CAS No.	145108-58-3
Molecular Formula	C13H16N2 • HCl
Molecular Weight	236.74 g/mol (Free base: 200.28)
Synonyms	Dexmedetomidine HCl; (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole Hydrochloride; MPV-1440; Precedex Active Pharmaceutical Ingredient; Dexdor; (+)-Medetomidine Hydrochloride; Dexmedetomidine Monohydrochloride
EINECS	Contact for details

Quality Control

Our Dexmedetomidine Hydrochloride is manufactured under strict quality systems and undergoes comprehensive analytical testing to ensure it meets the highest purity standards for pharmaceutical use. Quality is assured through rigorous protocols aligned with ICH guidelines and current Good Manufacturing Practices (GMP). Each batch is supported by a detailed Certificate of Analysis (COA) documenting identity, purity, and impurity profiles. Specifications can be tailored to meet USP, EP, or client-specific 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). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Optical Rotation	Specific range provided on COA
Microbial Limits	Meets EP/USP requirements for non-sterile API

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