Biomaterial
Human Plasma Derivatives (Albumin)
HS3002.11.00Standard
Human serum albumin (HSA) and related plasma-derived proteins are produced from human plasma at licensed fractionation facilities operating under EU GMP and WHO TRS 924. Albumin is supplied as 4% or 20% solution in 50–500 mL glass vials. DRMRC specialises in biomedical procurement for clinical institutions and SFERA facilitates international trade of these regulated biologics. All products are subject to viral inactivation (pasteurisation 60C/10h), full donor screening, and conform to Ph.Eur. 0255.
Specifications
| Albumin content | ≥96% of total protein |
| Protein concentration | 50 g/L (5%) or 200 g/L (20%) |
| pH | 6.4–7.4 |
| Sodium | 130–160 mmol/L |
| Potassium | ≤2 mmol/L |
| Haemoglobin | ≤50 mg/L |
| Viral inactivation | Pasteurisation 60C / 10 hours |
| Endotoxins | ≤0.5 IU/mL |
| GMP compliance | EU GMP licensed fractionation facility |
| Regulatory | WHO-approved process; import permit required |
| Quality Assurance | Independent inspection at loading port |
Logistics
| Loading Ports | Novorossiysk, St. Petersburg |
| Lot Size | Per purchase order; min. 1,000 units |
| Transit Estimate |
Reference Pricing
⚠ Indicative only. Final CIF price confirmed in your Full Corporate Offer.
Documentation Requirements
- EU batch release cert
- CoO
- GMP cert
- Ph.Eur. CoA