Leech Biotechnology, Defining New Standards of Potency.
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| Place of Origin: | China |
|---|---|
| Brand Name: | yichilam |
| Certification: | ISO9001；ISO45001；ISO12001；FDA；GMP |
| Model Number: | yzl-d-011 |
| Packaging Details: | Standard Packages |
| Delivery Time: | 10-20 Days |
| Payment Terms: | T/T, L/C, D/P, Western Union |
| Supply Ability: | Medical leech factory: annual output > 100 million medical leeches |
| Productname: | Leech Powder | Latin Name: | Hirudo Nipponia |
|---|---|---|---|
| Content: | 500ATU/g | Shelf Life: | 36 Months |
| Store: | Freeze | Purity: | ≥98% |
| Highlight: | Ultra High Potency Hirudo Nipponica Powder,Ultra High Potency Leech Extract,Food Grade Hirudo Nipponica Powder |
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Pinnacle Potency Leech Powder represents the absolute zenith of our bioengineering capabilities—a product that transforms the theoretical limit into a commercially available reality. With a guaranteed specific activity of ≥ 900 Anti-Thrombin Units (AT-U) per gram, this material is no longer merely a nutraceutical ingredient; it is a high-purity pharmaceutical-grade bioactive substance. It is exclusively engineered for the most demanding frontiers of biomedical research, advanced therapeutic development, and as the definitive global reference standard for hirudin potency.
| Parameter | Specification & Certification |
|---|---|
| Source & Genetic Identity | Hirudo nipponica. |
| Guaranteed Specific Activity | ≥ 900 AT-U/g . |
| Manufacturing Standard | Manufactured in an ISO 9001 certified, dedicated suite operating under Pharmaceutical cGMP principles. Full batch genealogy and electronic batch records maintained. |
| Physical & Chemical Properties | Lyophilized, amorphous powder. |
| Ultimate Purity Profile | Pure natural leech powder. Heavy metals and aflatoxins meet EU standards.. |
| Stability & Validation | Supported by a formal Stability Program per ICH Q1A-Q1E. Real-time data confirms conformational and activity stability. A validated Stability-Indicating Method (SIM) is established for release and shelf-life monitoring. |
1. The 900 AT-U/g Benchmark – Redefining the Possible
This concentration establishes an unprecedented efficacy-to-mass ratio, enabling revolutionary research in micro-dosing, local delivery systems, and the development of products where excipient load must be minimized to near-zero.
2. Proprietary "SynBio-Expression & Cryo-Preservation" Platform
This potency is achievable only through our integrated, patent-protected platform:
SynBio-Informed Cultivation: Leveraging insights from synthetic biology, our controlled ecosystem optimizes every parameter for maximal bioactive peptide expression, far exceeding natural wild-type yields.
Instant Cryogenic Immobilization (ICI): Within seconds of harvest, material undergoes a proprietary cryogenic process that "freezes" the native proteomic state, virtually eliminating enzymatic degradation and delivering the highest possible intact bioactive yield to the extraction process.
3. Designed for Critical, High-Value Applications
This material is the cornerstone for:
Investigational New Drug (IND)-enabling studies and pre-clinical pharmacodynamics/pharmacokinetics (PD/PK) research.
Advanced formulation of medical devices (e.g., bioactive coatings for vascular grafts).
Development of a United States Pharmacopeia (USP) or European Pharmacopoeia (Ph. Eur.) Reference Standard.
Groundbreaking in-vitro diagnostic (IVD) assay development for thrombosis risk.
4. A Partnership in Advanced Science
Supply of the 900 AT-U/g powder includes eligibility for our Pinnacle Partnership Program. This provides collaborative access to foundational non-clinical data, regulatory consultation support for specific pathways, and co-development opportunities for proprietary applications.
Pharmaceutical R&D & Clinical Research: The definitive source material for early-stage drug discovery, mechanism-of-action studies, and as a comparator in biosimilar development programs.
Advanced Medical Material Science: For research into next-generation hemo-compatible materials, wound healing matrices, and targeted drug delivery platforms.
Global Metrology & Standards: As a candidate for becoming an international primary biological reference material, ensuring consistency and accuracy in hirudin quantification worldwide.
Ultimate-Concentration Nutraceutical Prototyping: For formulating a single product that defines the absolute upper limit of the market, targeting exclusive professional and concierge wellness channels.
Primary Packaging: 1 kg, double aluminum foil bag to ensure maximum stability and shelf life. Custom packaging options are available.
Storage Instructions: Must be stored at -20°C (± 5°C) for long-term preservation.
Shelf Life & Handling: 48 months at -20°C from date of manufacture.
This product is the masterpiece of Jingzhou Min Kang Biotechnology Co., Ltd., an enterprise that has evolved from a cultivator to the global architect of Hirudo nipponica-based bioactives.
Unrivaled Vertical Mastery: Our control is total. From the exclusive genetics of our HiruMax strains bred at our provincial-certified farm, through our patented low-temperature bioactive extraction process (专利号 CN201610814087.2), to final aseptic handling—every variable is controlled, optimized, and documented. We are the sole source with this depth of integration.
Science as Our Foundation: Our collaborations, such as the joint R&D platform with Hubei University of Chinese Medicine, are not symbolic; they drive our innovation. The 54.75% hyaluronidase inhibition rate verified in third-party labs (如亿腾检测报告 YT2440844) for our downstream products is a testament to the preserved bioactivity originating from our raw materials.
A Recognized Leader: As a National High-Tech Enterprise and the subject of features on programs like CCTV's Influential Era, our role in modernizing traditional medicine through science is nationally acknowledged. Our GMP and GAP certifications are operational necessities, not just accolades.
Our Promise and Vision: We provide more than a powder; we provide access to a frontier. Choosing the 900 AT-U/g Pinnacle Potency powder is an investment in a partnership with the company that writes the scientific and commercial rules for high-potency hirudin applications.
Critical Notice:
Product Type: Raw Material. Target Users: Qualified manufacturers and researchers only. Not for consumer use. Specifications are defined per our factory standards. A CoA is available per batch upon request.