| Quality Standards & Operations | |
|---|---|
| Regulation Certification | U.S. FDA, CEP, KOSHER, HALAL, GMP, ISO Certificates |
| Reliable Quality | Nearly 20 years of exporting experience to 40 countries and regions. More than 2000 produced batches without quality issues. Featuring a unique purification process, impurity and purity control meets USP, EP, and CP standards. |
| Comprehensive Quality System |
Quality Assurance System
Document control
Validation System
Training System
Internal Audit Protocol
Supplier Audit System
Equipment Facilities System
Material Control System
Production Control System
Packaging Labeling System
Laboratory Control System
Verification Validation System
Regulatory Affairs System
|
| Control of Sources & Processes | Strictly controlled raw materials, accessories, and packaging materials. Preferred suppliers holding U.S. DMF numbers. Backup raw material suppliers are utilized to guarantee a stable supply. |
| Strong Cooperative Institutions | Supported by renowned Institute of Botany, Institute of Microbiology, Academy of Science and Technology, and leading universities. |
Leech Hirudin is a naturally occurring peptide extracted from the salivary glands of medicinal leeches. It acts as a highly potent and selective inhibitor of thrombin, making it highly effective for anticoagulant and antithrombotic purposes.
Our Leech Hirudin has a CAS number of 113274-56-9. It features an assay of 800 fu/g ≥ 98.0% by UV, and appears as a white or yellowish powder with a characteristic odor and taste.
Unlike heparin, Hirudin does not rely on endogenous cofactors (such as antithrombin III) to exert its effects, meaning it requires lower dosages and works effectively even when antithrombin levels are depleted. Additionally, it does not induce hemorrhaging risks typical of heparin therapies.
Leech Hirudin should be kept in its original, unopened container and stored in a cool, dry place. It must be shielded from strong light. Under these conditions, the product maintains a shelf life of 24 months from the production date.
Our manufacturing operations conform to strict international regulatory standards. The product is backed by certifications including U.S. FDA, CEP, KOSHER, HALAL, GMP, and ISO.