|
Item
|
Specifications
|
|
Characters
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A white freeze-dried powder
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|
Identification
|
Positive
|
|
Peptide mapping
|
Similar to the standard solution
|
|
pH
|
6.5-8.5
|
|
Assay(HPLC)
|
As 95.0-110.0% of the marked dosage
|
|
Bioidentity
|
Conformed with USP30 Standard
|
|
Water Content
|
≤10.0%
|
|
Microbio limits
|
≤300cfu/g
|
|
Safety Test
|
Mouse Test:Conformed
|
|
Cavy Test:Conformed
|
|
|
Bacterial Endotoxin
|
≤5EU/mg
|
|
Dimers Content (HPLC)
|
1%~2%
|
|
High Molecular Protein(HPLC)
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≤4%
|
|
Related Protein Content (RP-HPLC)
|
≤6.0%
|
|
Potency
|
3.0±0.3IU/mg
|
Specifications︰ CAS:12629-01-5
