Alirocumab NEW

2. pH value

Corresponds to reference standard

Pass

3. Purity

NLT 99.0%

Pass

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