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产品名称:

阿特朱单抗

标准
1. Concentration60.0±6.0mg/ml61.0 mg/ml2. pHvalueCorrespondstoreferencestandardPass3. Purity  3.1Non-reducedCE-SDSMainpeakNLT90.0%98.4%3.2SEC-HPLCMainpeakNLT95.0%99.1%4. IsoelectricPointCorrespondstoreferencestandardPass5. BacterialEndotoxinsTest<5EU/ml<1 EU/ml6. ResidualProteinsofHostCell≤100ng/mg1 ng/mg7. ExogenousResidualDNA≤100pg/mg<1pg/mg8. ResidualproteinA≤100ng/mg<1ng/mg9. BiologicalActivityComparedwithstandard,therangeofbiologicalactivityisfrom80%to125%.113%10. OsmolalityCorrespondstoreferencestandardPass11. PeptidemappingCorrespondstoreferencestandardPass12. N-terminalsequenceCorrespondstoreferencestandardPass
CAS 编号:
1380723-44-3
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产品描述

1. Concentration

60.0±6.0 mg/ml

61.0 mg/ml

2. pH value

Corresponds to reference standard

Pass

3. Purity

 

 

3.1 Non-reduced CE-SDS

Main peak NLT 90.0%

98.4%

3.2 SEC-HPLC

Main peak NLT 95.0%

99.1%

4. Isoelectric Point

Corresponds to reference standard

Pass

5. Bacterial Endotoxins Test

5 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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