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 |
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