Etanercept CAS NO.185243-69-0

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