Imagine your bloodstream as a 24/7 highway. Normally, traffic flows smoothly. But when a rupture occurs - a cut, a surgical incision - the body deploys an emergency SWAT team: platelets and clotting factors rush to the scene to build a "roadblock" (a clot). This saves your life.
But what happens when the SWAT team doesn't stand down? In conditions like deep vein thrombosis, pulmonary embolism, or during cardiac surgery, the cascade overshoots. Clots form where they are not wanted. That's where Heparin Sodium enters.
Heparin is not a clot‑buster. It does not dissolve existing clots. Instead, it is a silencer. It whispers to the clotting cascade: "Stand down."
Mechanism of Action: Heparin binds to Antithrombin III (ATIII), inducing a conformational change that accelerates ATIII's inhibition of Thrombin (Factor IIa) and Factor Xa by 1,000 to 10,000‑fold. By neutralizing these key factors, Heparin prevents fibrinogen from being converted into fibrin - the sticky mesh that holds a clot together.
The "Polydisperse" Nature: Unlike a small molecule drug with a single molecular weight, Heparin is polydisperse - a mixture of polysaccharide chains ranging from 3,000 to 30,000 Daltons. This heterogeneity is not a flaw; it is the source of its unique potency profile.
Specification: ≥150 USP units / mg (Min.; High Potency Grade)
Sample: Sample Available (Restricted: NDA & License Required)
Test method: USP Rabbit Plasma Clotting Assay / HPLC
Synonyms: Heparin sodium salt, Unfractionated Heparin (UFH), Mucopolysaccharide polysulfate
MOQ: 10 KG (Stringent regulatory chain required)
Package: Sterile, double-sealed pharmaceutical drums
Certificate: GMP, ISO 22000, Animal-Free (Porcine Intestinal) Origin Certification
Molecular Formula: (C₁₂H₁₆NS₂Na₃O₂₀)n | CAS: 9041-08-1
Product Characteristics
Potency
Molecular Weight (Polydisperse)
Solubility
Appearance
Storage
GMP Manufacturing
COA (Certificate of Analysis)
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Benefits of Heparin Sodium Powder
01Rapid Onset of Action (Intravenous)
When administered intravenously, Heparin acts immediately (within seconds). It is the anticoagulant of choice for acute settings: surgery, hemodialysis, and emergent treatment of thromboembolic events.
02Reversibility
Unlike newer oral anticoagulants (DOACs), Heparin's effect can be reversed immediately with protamine sulfate. This makes it the safer choice in high‑risk surgical settings.
03Extensive Clinical History
Heparin has been in clinical use for over 80 years. Its safety profile, dosing, and contraindications are exhaustively documented. No "unknown unknowns."
04Dual Mechanism (Anti‑Xa and Anti‑IIa)
Unfractionated Heparin inhibits both Factor Xa (the amplifier) and Thrombin (the effector). For certain clinical scenarios (e.g., cardiac bypass surgery), the dual inhibition of UFH is preferred.
05Predictable Dose‑Response with Monitoring
While Heparin has a narrow therapeutic window, its effect is easily monitored via aPTT. Dosing can be adjusted in real‑time based on lab results.
06Safe in Pregnancy
Heparin does not cross the placenta and is the anticoagulant of choice during pregnancy (for conditions like DVT, mechanical heart valves).
Application Fields
Surgical Anticoagulation: Prevents clot formation during cardiac surgery (cardiopulmonary bypass), vascular surgery, and orthopedic procedures.
Hemodialysis: Prevents clotting in the extracorporeal circuit during kidney dialysis.
Deep Vein Thrombosis (DVT) & Pulmonary Embolism (PE): Treatment and prophylaxis.
Acute Coronary Syndromes (ACS): Used in combination with antiplatelet agents.
Central Venous Catheter (CVC) Lock: Small volumes of Heparin solution keep catheters patent.
Blood Collection Tubes: Heparin‑coated tubes (green top) provide plasma for laboratory tests.
Production Process
Product Quality Advantage
≥150 USP units/mg – High potency, batch‑to‑batch consistency.
Low Endotoxins – ≤0.01 EU/mg (exceeds USP requirements).
Low Protein Impurities – ≤0.03% (low immunogenicity risk).
Controlled Molecular Weight – Consistent anticoagulant profile.
Animal Origin Traceability – Porcine intestinal mucosa, full documentation.
cGMP Certified – Sterile injectable manufacturing.
Annual Capacity: 1,500 Tons | 15+ years of pharmaceutical ingredient expertise
Professional ODM/OEM Services
We provide full contract manufacturing for Heparin Sodium finished dosage forms - exclusively for licensed pharmaceutical partners.
① Finished Dosage Forms
Heparin Sodium Injection Vials: Multi‑dose vials (1,000; 5,000; 10,000; 20,000 USP units/mL).
Heparin Sodium Pre‑filled Syringes: Single‑dose, ready‑to‑administer.
Heparin Flush Syringes: For CVC maintenance (10 or 100 USP units/mL).
Heparin Lock Solution: For hemodialysis catheters.
Lyophilized Heparin Vials: For extended shelf life and custom reconstitution.
Heparin‑Coated Medical Devices: Catheters, tubing (specialized coating line).
② Regulatory Support
ANDA/NDA documentation, stability studies (ICH guidelines), serialization and track‑and‑trace packaging (DSCSA compliance), veterinary Heparin formulations.
③ Restricted Access
This product is NOT available for dietary supplement use. Sales require a valid end‑use declaration and, in some cases, an import license. Contact us for compliance guidance.
Export Certificates
Why choose us
XI'AN LANDNUTRA CO., LTD. – Your Trusted Manufacturer of Pharmaceutical & Functional Ingredients. Rooted in Quality, Driven by Expertise, Committed to Health and Excellence.
Strong Production Capability: Annual capacity 1,500 tons. 15+ years experience, own facility.
Leading Service: ONE-STOP OEM/ODM from pre-sales to after-sales.
Quality Assurance: CQC-certified enterprise, purity embedded in every process.
Broad Market: Pharmaceutical APIs, Botanical Extracts, Cosmetic Ingredients, Functional Ingredients.
We are a pharmaceutical ingredient supplier with 15+ years of experience in complex polysaccharide purification. cGMP‑certified for sterile injectable manufacturing. Full traceability from animal source to finished vial. Regulatory documentation for US FDA, EMA, and other global authorities. Batch‑specific COA including potency, anti‑Xa/anti‑IIa activity, molecular weight, endotoxins, and heavy metals.
FAQ
| Test Item | Specification (USP/EP Injectable Grade) | Test Result | Conclusion |
|---|---|---|---|
| Appearance | Off-white to pale cream amorphous powder | Conforms | Pass |
| Potency (USP assay) | ≥150 USP units/mg | 162 USP units/mg | Pass |
| Anti-Factor Xa Activity | 140 – 180 IU/mg | 158 IU/mg | Pass |
| Anti-Factor IIa Activity | 130 – 170 IU/mg | 149 IU/mg | Pass |
| Ratio (Anti-Xa / Anti-IIa) | 0.9 – 1.1 | 1.06 | Pass |
| Molecular Weight (Mw) | 15,000 – 19,000 Da | 17,200 Da | Pass |
| pH (1% solution) | 5.0 – 7.5 | 6.4 | Pass |
| Loss on Drying | ≤5.0% | 2.8% | Pass |
| Heavy Metals (as Pb) | ≤10 ppm | <2 ppm | Pass |
| Bacterial Endotoxins | ≤0.03 EU/mg | <0.01 EU/mg | Pass |
| Protein Impurities | ≤0.1% | 0.03% | Pass |
| E. Coli / Salmonella | Negative | Negative | Pass |
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