ORCHID CHEMICAL SUPPLIES LTD
Assessed Supplier Enterprise Certification
- Assessed
Supplier - 16th
years
Assessed Supplier Enterprise Certification
Business Type:Other
Product Certification&
Enterprise Certification
Country: 
China (Mainland)
Business Type:Other
Tel: +86-571-85395792
Tel: 0571-85395792
Tel: 15858279064（WhatsApp）
Tel: 0571-85395796
Tel: 13588126495(whatsapp)
Tel: 0571-56508104
Tel: +86-57156508100
Mobile:
Tel: +86-571-85395792
Fax: +86-571-85395793
URL: http://www.orchid-chem.com
Province/state: Zhejiang
City: Hangzhou
Street: 607, North Zhongshan Road, Hangzhou 310000 China
MaxCard:
Ms.Tracy Chen Ms.Daisy Ge
1. Product Name: Etanercept
2. CAS No.: 185243-69-0
3.Specification1: Injection
4. Specification2: Pre-filled Syringe
| Items | Specification | Results |
| Protein content | ≥30.00mg/ml | 37.24mg/ml |
| Biological activity | ≥8.0*104AU /mg | 10.8 *104AU /mg |
|
Purity by Electrophoresis
|
Purity of monomer ≥88% Content of large molecules ≤6.0% Content of small molecules ≤8.0%
|
Monomer: 98.2% Large molecular: 1.4% Small molecular: 0.4%
|
| Purity by SEC-HPLC | ≥95.0% | 97.8% |
| Purity by RP-HPLC | ≥95.0% | 100.0% |
| Molecular weight | 63.0~77.0 kDa | 69.6 kDa |
| UV absorption | Max. at 280nm±3nm | 279.6nm |
| Isoelectric Point | 4.8±0.5, Identical to the reference stanard | complies |
| Content of Sialic acid | 100%±30%of that of the reference standard | 106% |
| Residue of exogenous DNA | ≤100pg/25mg protein | complies |
| residue of CHO host cell protein | ≤0.03% of total protein | 0.00107% |
| Bacterial endotoxin | <2EU/mg protein | <1EU/mg protein |
| Peptide map | Identical to that of reference standard | complies |
| residue of rProtein A | not more than 0.01% of total protein | complies |
| Sequence of 15 Amino Acide at N-terminal | Leu Pro Ala Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly | |
| Conclusion | The quality of this batch bulk product complies with Speicification | |