Detailed Description
1 Appearance White powder Conforms
2 Solubility Soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution Conforms
3 Identity by HPLC The retention is same with the reference substance Conforms
4 Amino Acid Composition ±10% of theoretical Conforms
5 Peptide Purity (By HPLC) ≥ 98.0% by area integration 98.7%
6 Related Substance(By HPLC) Total Impurities(%) ≤ 2.0% Largest Single Impurity (%) ≤ 2.0% 1.3% 1.3%
7 Acetate Content ≤ 15.0% 8.6%
8 Water Content (Karl Fischer) ≤ 5.0% 3.6%
9 Assay (by anhydrous, acetic acid-free) 95.0 ∼105.0% 98.5%
10 Specific Optical Rotation -85 ~ -100o (c=1,1%HAc) -92.8o
11 Bacterial Endotoxins ≤5 IU/mg Conforms
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