Somatropin

Characters

A white freeze-dried powder

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)

≤4%

Related Protein Content (RP-HPLC)

≤6.0%

Potency

3.0±0.3IU/mg