API Heparin

Heparin More Info

Heparin is a naturally occurring glycosaminoglycan (GAG) primarily extracted from porcine intestinal mucosa or bovine lung. As a highly sulfated polysaccharide, it serves as a critical anticoagulant in clinical practice and pharmaceutical manufacturing, with widespread applications across global healthcare markets.

Basic Specifications

CAS No.: 9005-49-6

Molecular Weight: Unfractionated Heparin (UFH) ranges from 3,000 to 30,000 Da; Low-Molecular-Weight Heparin (LMWH) typically falls between 3,000 and 8,000 Da

Potency: UFH exhibits 150–190 IU/mg; LMWH (e.g., Enoxaparin, Dalteparin) has anti-Xa activity of 100 IU/mg

Physical Form: White to off-white powder, soluble in water but insoluble in organic solvents such as ethanol and acetone

Purity: Minimum 95% purity confirmed by HPLC, compliant with international pharmacopoeia standards including USP/NF, EP, BP, and ChP

Impurity Control: Residual protein content ≤0.5%, heavy metals ≤10 ppm, endotoxin ≤0.1 EU/mg

Core Applications

Pharmaceutical Manufacturing: Key raw material for injectable anticoagulants used in preventing deep vein thrombosis (DVT), pulmonary embolism (PE), and treating myocardial infarction; serves as the base for LMWH derivatives with improved pharmacokinetic profiles

Medical Devices: Coating material for catheters, heart valves, and dialysis equipment to inhibit thrombosis formation during clinical use

Research & Laboratory Use: Essential anticoagulant for cell culture protocols and blood sample processing in academic and industrial research settings

Trade & Regulatory Considerations

Market Dynamics: Global demand is driven by aging populations and rising incidence of cardiovascular diseases; LMWH dominates outpatient settings due to longer half-life and reduced monitoring requirements compared to UFH

Quality Compliance: Mandatory adherence to international pharmacopoeia standards (USP/NF, EP) for cross-border trade; strict control of animal-derived impurities (e.g., prions) and microbial contamination is required

Packaging & Storage: Supplied in vacuum-sealed foil bags (1kg) or food-grade HDPE drums (25kg) to ensure stability; shelf life of 2 years when stored in dry, cool conditions (15–25°C) away from direct sunlight

Export Requirements: Customs clearance requires submission of Certificate of Analysis (CoA), GMP certification, and Free Sale Certificate (FSC); major target markets include North America, Europe, Southeast Asia, and Latin America.