Heparin Sodium API | Anticoagulant Pharmaceutical API Manufacturer in India

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Heparin Sodium API

Heparin Sodium is a biological anticoagulant composed of sulfated glycosaminoglycan chains. It exerts its anticoagulant effect primarily by enhancing the activity of antithrombin, which inhibits key coagulation enzymes including thrombin (factor IIa) and factor Xa.

Heparin Sodium is widely used in pharmaceutical formulations for the prevention and treatment of venous and arterial thromboembolic conditions and for maintaining anticoagulation during certain medical procedures.

Heparin Sodium API Manufacturer in India

Heparin Sodium is a specialized biological pharmaceutical API. Unlike conventional synthetic small-molecule APIs, it is a heterogeneous polysaccharide material whose quality depends on source material, extraction, purification, molecular-weight distribution, anticoagulant activity and impurity control.

Pharmaceutical-grade Heparin Sodium requires extensive analytical characterization and control of biological and microbiological impurities.

Biological Information

Product Name: Heparin Sodium
Common Name: Unfractionated Heparin
CAS Number: 9041-08-1
Molecular Formula: Variable / polymeric
Molecular Weight: Variable; typically approximately 12–15 kDa for unfractionated heparin
Drug Class: Anticoagulant
Pharmacological Class: Heparin / Antithrombin Activator
Therapeutic Class: Antithrombotic
Therapeutic Area: Hematology / Cardiovascular Medicine

Mechanism of Action

Heparin binds to antithrombin (AT) and produces a conformational change that substantially accelerates antithrombin-mediated inhibition of activated coagulation factors.

Its anticoagulant activity is primarily associated with inhibition of factor Xa and thrombin (factor IIa). Heparin therefore reduces thrombin generation and fibrin formation, limiting the development and extension of blood clots.

Pharmaceutical Applications

Heparin Sodium is used for:

  • Prevention of venous thromboembolism
  • Treatment of deep vein thrombosis
  • Treatment of pulmonary embolism
  • Prevention and treatment of thromboembolic complications
  • Anticoagulation during cardiovascular procedures
  • Anticoagulation during extracorporeal circulation and hemodialysis
  • Certain acute coronary and thrombotic conditions

Specific uses depend on the formulation, dosage and approved product labeling.

Heparin Sodium in Anticoagulant Therapy

Heparin provides rapid anticoagulant activity and is particularly useful when immediate modulation of coagulation is required. Its biological activity is commonly standardized using international units (IU) rather than relying solely on a conventional mass-based assay.

Physical and Chemical Properties

Heparin Sodium is a highly sulfated, negatively charged polysaccharide supplied as the sodium salt. It is generally obtained as a white or nearly white hygroscopic powder and is readily soluble in water.

Because heparin consists of heterogeneous polysaccharide chains, it does not have a single defined molecular formula or molecular weight like a conventional small molecule.

Quality and Analytical Testing

Heparin Sodium API quality evaluation may include:

  • Identification by NMR
  • Infrared spectroscopy
  • Molecular-weight distribution
  • Anticoagulant potency
  • Anti-factor Xa activity
  • Anti-factor IIa activity
  • HPLC/SEC analysis
  • NMR structural characterization
  • Residual proteins
  • Nucleic acids
  • Bacterial endotoxins
  • Microbial limits
  • Residual solvents where applicable
  • Sodium content
  • Moisture / water content
  • Oversulfated chondroitin sulfate and other specified impurities

Storage

Heparin Sodium should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage requirements should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Heparin Sodium remains an important biological anticoagulant for pharmaceutical research involving coagulation pathways, antithrombin activity, thrombin inhibition and factor Xa inhibition.

Heparin Sodium API Summary

Heparin Sodium is a biological anticoagulant polysaccharide with CAS Number 9041-08-1. Unlike conventional small molecules, it has a variable molecular structure and molecular-weight distribution. Its anticoagulant activity is primarily mediated through enhancement of antithrombin activity against factor Xa and thrombin.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
pH (1% Solution) 5.5 – 8.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
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