High Purity Dexmedetomidine HCl 99.5% USP/EP Pharma Grade Sedative API | China | Manufacturer

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Product Details

Product Name: Dexmedetomidine hydrochloride	CAS No.: 145108-58-3
EC-No.: 213-559-2	Min. Order: 0.01KG
Purity: 99%	Supply Ability: 500
Release date: 2025/12/05

Wholesale High Purity Dexmedetomidine HCl 99.5% USP/EP Pharma Grade Sedative API

Chemical Name：Dexmedetomidine hydrochloride

CAS:145108-58-3

Molecular Formula:C₁₃H₁₇ClN₂

Molecular Weight:236.74 g/mol

Appearance:White or almost white crystalline powder

Solubility:Freely soluble in water, sparingly soluble in ethanol, practically insoluble in dichloromethane

Melting Point:Approximately 160-164°C (with decomposition)

pKa (Dissociation Constant):~7.1 (basic imidazole nitrogen)

Partition Coefficient (Log P):~1.3 (lipophilic at physiological pH)

Optical Rotation:+15° to +18° (c = 1 in water, at 20°C)

Storage Conditions:Store below 25°C, protected from light and moisture

Stability:Stable under recommended storage conditions; incompatible with strong oxidizing agents

Certificate of Analysis (COA) – Dexmedetomidine Hydrochloride

Parameter	Specification	Test Method	Results
Identification	Complies with reference standard (HPLC/IR)	HPLC, IR, or NMR	Complies
Appearance	White to off-white crystalline powder	Visual inspection	White powder
Assay (HPLC)	98.0% – 102.0% (anhydrous basis)	USP/Ph. Eur. HPLC method	99.5%
Water Content (KF)	≤ 1.0% w/w	Karl Fischer titration	0.4%
Residue on Ignition	≤ 0.1%	USP <281>	0.05%
Heavy Metals	≤ 20 ppm	ICP-MS or USP <231>	<10 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%, Total ≤ 1.0%	USP/Ph. Eur. impurity method	Max 0.2% (Total 0.6%)
Optical Rotation	+15° to +18° (c=1 in water)	Polarimetry	+16.5°
pH (1% solution)	4.5 – 7.0	Potentiometric method	5.2
Microbial Limits	TAMC ≤ 1000 CFU/g, TYMC ≤ 100 CFU/g	USP <61>	Complies
Endotoxins	< 5.0 IU/mg (if for injectable use)	LAL test (USP <85>)	<1.0 IU/mg
Particle Size (if applicable)	As per customer requirement	Laser diffraction (USP <429>)	D90 ≤ 50 µm

Competitive Advantages of Wuhan HR Biotechnology Co.,ltd

Core Strengths	Specific Highlights
Supply Chain Excellence	• Integrated manufacturing & QC processes • Strategic partnerships with 100+ certified suppliers • MOQ flexibility (from samples to bulk orders)
Global Compliance	• Certifications: ISO 9001, CE, FDA, REACH, etc. • Strict adherence to international trade regulations • Eco-friendly packaging options
Technology Edge	• Advanced production equipment (e.g., CNC/automated lines) • R&D team with 15+ years industry expertise • Custom OEM/ODM solutions
Logistics Efficiency	• 30-day standard delivery to major ports worldwide • Partnerships with DHL/Maersk/FedEx • Real-time shipment tracking
Customer-Centric Service	• Dedicated multilingual support team (English/Spanish/Arabic/etc.) • 24/7 pre-sales & after-sales assistance • On-demand technical documentation
Cost Optimization	• Raw material sourcing from top-tier suppliers • Energy-efficient manufacturing • 5-15% cost advantage vs. competitors
Quality Assurance	• Triple-inspection system (pre/mid/post-production) • 0.37% avg. defect rate • Lifetime product support
Market Reputation	• Serving 50+ countries since [Year] • Featured clients: [Industry-leading brands] • 98.2% positive feedback rate

Company Profile Introduction

Wuhan Hao Rong Biotechnology Co., Ltd., located in East Lake high tech Development Zone, Wuhan, is a company specializing in the production and operation of chemical raw materials, flavors and fragrances, food additives, agrochemicals and other products. The company has first-class production equipment, advanced production technology, scientific management system, perfect detection means, and an excellent R & D team. The R & D center of the company has a technical team specialized in research and development, as well as a number of advanced detection, experiment and pilot equipment, and has established a good technical support relationship with a number of scientific research institutions, with strong technical force. The company has a wide range of products, in line with the quality of survival, service and development, customer-centric, integrity management philosophy, do our best to provide customers with quality and cheap raw materials. In addition, haorong also helps customers develop and implement customized system solutions. In these core areas of the chemical industry, haorong's core expertise covers chemicals and application technology, flexible asset management and customized services.

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Wuhan Haorong Biotechnology Co.,ltd