HK Neopharm Limited is one of the most reliable manufacturers and suppliers of dexmedetomidine hydrochloride injection in China, featured by quality products and good price. Please rest assured to buy dexmedetomidine hydrochloride injection in stock here and get quotation from our factory. Customized orders are welcome.
Dexmedetomidine HCl Injection is a highly selective α₂-adrenergic receptor agonist for intravenous sedation. As a core sedative in perioperative and intensive care settings, it features unique clinical advantages including sedation, analgesia, anxiolysis, stable hemodynamics, and no significant respiratory depression. It is the preferred sedative recommended by anesthesia and ICU guidelines worldwide.
Technical Specifications
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Product Name |
Dexmedetomidine hcl injection |
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Synonyms |
Dexmedetomidine HCl Injection |
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Characteristics |
Colorless clear liquid |
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CAS Number |
145108-58-3 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C₁₃H₁₆N₂·HCl |
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Package |
Technical Package |
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Storage |
Store at 2-8℃ |
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Structure |
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Produced from high-purity dexmedetomidine hydrochloride raw materials using sterile preparation technology, Dexmedetomidine 1ml and Dexmedetomidine 2ml feature strict impurity control, excellent stability, and outstanding batch-to-batch consistency. They meet the full-scenario clinical demands of general anesthesia adjuvant sedation, ICU mechanical ventilation sedation, preoperative anxiolysis, and procedural sedation, providing safe, controllable, and arousable high-quality sedation solutions for anesthesia and critical care medicine.
Product Features
Dexmedetomidine HCl Injection achieves an arousable, easily awakened sedation state with clear consciousness by selectively stimulating α₂ receptors in the locus coeruleus, mimicking natural sleep. This distinguishes it from conventional sedatives and enhances clinical safety and flexibility.
High respiratory safety: No significant respiratory depression at effective sedative doses, significantly reducing respiratory management risks in ICUs and perioperative settings.
Stable hemodynamics: Inhibits excessive sympathetic activation, stabilizes heart rate and blood pressure, reduces myocardial oxygen consumption and stress injury, and improves perioperative safety.
Synergistic analgesic effect: Enhances the efficacy of opioids and anesthetics, reduces their dosage, and lowers adverse reactions such as nausea, vomiting, and delayed recovery.
Anxiolysis and anti-shivering: Relieves preoperative anxiety and intraoperative stress, effectively prevents and treats post-anesthetic shivering, and improves patient comfort.
Manufactured in strict compliance with international GMP standards in a B+A grade cleanroom environment, Dexmedetomidine 0.1mg and Dexmedetomidine 0.2mg undergo terminal sterilizing filtration, aseptic filling, 100% visual inspection, and pyrogen testing to ensure sterility, pyrogen-free, and particle-free quality. Key indicators including related substances, enantiomers, pH value, and osmotic pressure meet pharmacopoeia and ICH requirements. Stable batches and traceable data provide reliable support for formulation development, consistency evaluation, and registration applications.
Full-Cycle Quality Control & Consistent Quality
Quality is the core competitiveness of Dexmedetomidine HCl Injection. We have established a full-process quality control system from raw material incoming to finished product release, supporting clinical medication and pharmaceutical R&D and registration with stable and reliable quality.
Raw material and preparation controlOnly high-purity dexmedetomidine hydrochloride raw materials complying with pharmacopoeia standards are used and fully tested before use. Preparations are made with sterile water for injection, with strict control of pH (4.0–6.0) and osmotic pressure. The formulation stability is optimized to prevent crystallization and degradation, controlling impurities and isomers from the source.
Sterile process and purification assuranceThe entire production is carried out under closed aseptic conditions, with 0.22μm sterilizing filtration, nitrogen-purged filling, and terminal sterilization to effectively control microorganisms, endotoxins, and visible particles. Finished products undergo multi-stage filtration and visual inspection to ensure clarity, stable characteristics, and full compliance with stringent safety requirements for injections.
Testing and release managementEach batch of Dexmedetomidine 1ml and Dexmedetomidine 2ml is supplied with a complete COA report covering description, identification, pH, related substances, isomers, assay, sterility, bacterial endotoxins, visible particles, and other full items. Testing data are fully traceable with excellent batch-to-batch consistency, meeting strict quality standards for clinical use, R&D pilot batches, and registration applications.
Product stability and consistencyA complete stability program including stress testing, accelerated testing, and long-term storage monitoring is established to verify stability under light-proof, cool, and sealed conditions. Degradation and impurity growth are effectively controlled, ensuring no significant changes in appearance, assay, and related substances throughout the shelf life, thus guaranteeing safe and effective clinical use.
Application Scenarios
Dexmedetomidine HCl Injection is mainly used for sedation in perioperative and intensive care settings, covering clinical and R&D scenarios in multiple departments:
Anesthetic and surgical sedation:
Sedation for endotracheal intubation and mechanical ventilation under general anesthesia, assisting induction and maintenance of anesthesia, stabilizing circulation, and reducing anesthetic dosage.
ICU critical care sedation:
Sedation for intubated and mechanically ventilated patients in intensive care units, with continuous infusion up to 24 hours, safe tolerance, easy arousal, and convenient patient evaluation.
Procedural sedation:
Sedation for short procedures including endoscopy, intervention, and radiology, providing anxiolysis, analgesia, and rapid recovery, improving compliance and comfort.
Preoperative / postoperative management:
Preoperative anxiety relief, postoperative shivering prevention and adjuvant analgesia, enhancing recovery quality and patient experience.
R&D and registration:
Used for formulation development, stability studies, consistency evaluation, pharmacodynamic and toxicological tests, as well as reference standards and test preparations for registration applications.
Packaging and Transportation
Considering the sensitivity of Dexmedetomidine HCl Injection to light and temperature, a full-process protection plan is customized to ensure stable quality from factory to delivery.
Light-proof sealed packaging:
Brown ampoules or light-protected vials for sterile packaging, plus light-proof cartons and shockproof packaging to prevent light-induced degradation and ensure sterility and clarity.
Temperature and humidity control:
Cool-chain transportation throughout with temperature controlled ≤20℃, equipped with real-time temperature and humidity monitoring to avoid high temperature and freeze-thaw cycles and maintain formulation stability.
Warehousing management:
GMP-compliant cool warehouses with separated storage and FIFO policy; regular stability sampling and shelf-life early warning to support R&D, pilot, and commercial supply.
Compliant transportation:
Qualified GSP-certified pharmaceutical logistics providers with full shock, drop, and contamination protection. Complete customs and documentation for international shipments to ensure global compliant delivery.
Full-chain traceability:
Full traceability from production, warehousing, transportation to delivery, with rapid response to abnormalities to ensure product safety and customer rights.
Our Advantages
Mature sterile process, stable quality Adopting proven injection manufacturing technology to ensure sterility, pyrogen-free, and visible-particle-free quality with excellent batch consistency. Full GMP compliance meets requirements of ChP, USP, and EP for clinical and registration use.
Precise impurity control, safe and reliable Strict control of related substances, isomers, residual solvents, and endotoxins, with accurate assay and high safety. Each batch provides complete COA, HPLC chromatograms, sterility and pyrogen reports to support registration applications.
Large-scale stable supply, reliable delivery Equipped with large-scale sterile production lines with sufficient inventory and stable delivery. Rapid response to small-scale, pilot, and commercial orders ensures continuous supply and reduces supply chain risks.
Complete compliance documents, comprehensive technical support Full set of GMP compliance documents, COA, MSDS, process data, and stability reports are available. Professional team supports formulation optimization, consistency evaluation, and registration dossier preparation with full technical support.
Professional packaging and storage, quality assurance Customized light-proof, sterile, shockproof packaging and cool storage and transportation solutions ensure full-process sterility, stability, and safety, guaranteeing products meet clinical and R&D standards upon delivery.
FAQ
If you are familiar with the sedative demands in perioperative and ICU settings and interested in the stable supply and professional supporting services of high-quality Dexmedetomidine HCl Injection, welcome to contact us for cooperation. We provide accurate and timely quotations, one-to-one technical support, and customized cooperation plans from R&D trials and pilot verification to commercial supply, offering stable and reliable preparation support for your anesthesia and critical care pharmaceutical projects.
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