1.?Concentration25.0±2.5?mg/ml25.1mg/ml2.?pHvalueCorrespondstoreferencestandardPass3.?Purity??3.1Non-reducedCE-SDSMainpeakNLT90.0%98.9%3.2SEC-HPLCMainpeakNLT95.0%99.4%4.?IsoelectricPointCorrespondstoreferencestandardPass5.?BacterialEndotoxinsTest＜3EU/ml＜1EU/ml6.?ResidualProteinsofHostCell≤100ng/mg＜1?ng/mg7.?ExogenousResidualDNA≤100pg/mg＜1?pg/mg8.?ResidualproteinA≤100ng/mg＜1?ng/mg9.?BiologicalActivityComparedwithstandard,therangeofbiologicalactivityisfrom80%to125%.113%10.?OsmolalityCorrespondstoreferencestandardPass11.?PeptidemappingCorrespondstoreferencestandardPass12.?N-terminalsequenceCorrespondstoreferencestandardPass

CAS 編號：

216974-75-3

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產品描述

1. Concentration	25.0±2.5 mg/ml	25.1 mg/ml
2. pH value	Corresponds to reference standard	Pass
3. Purity
3.1 Non-reduced CE-SDS	Main peak NLT 90.0%	98.9%
3.2 SEC-HPLC	Main peak NLT 95.0%	99.4%
4. Isoelectric Point	Corresponds to reference standard	Pass
5. Bacterial Endotoxins Test	＜3 EU/ml	＜1 EU/ml
6. Residual Proteins of Host Cell	≤100 ng/mg	＜1 ng/mg
7. Exogenous Residual DNA	≤100 pg/mg	＜1 pg/mg
8. Residual protein A	≤100 ng/mg	＜1 ng/mg
9. Biological Activity	Compared with standard, the range of biological activity is from 80% to 125%.	113%
10. Osmolality	Corresponds to reference standard	Pass
11. Peptide mapping	Corresponds to reference standard	Pass
12. N-terminal sequence	Corresponds to reference standard	Pass

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