Pramlintide Acetate

CAS NO 196078-30-5

Purity :98% min

 

1 Appearance White slightly yellowish powder White powder

 

2 Identity 3949.37±2.0 3950.2

3 Solubility Soluble in water or 1% acetic acid conforms

4 Amino Acid Composition ± 10% conforms

5 Peptide Purity (By HPLC) ≥98% by area integration 98.6%

6 Related Substance(By HPLC) Total Impurities (%)≤2.0% Largest Single Impurity (%)≤ 1.0% 1.4% 0.6%

7 Acetate Content ≤15% 9.8%

8 Water Content (Karl Fischer) ≤8.0% 4.2%

9 Peptide Content (N determination) ≥80% 85.3%

10 Bacterial Endotoxins ≤ 50 IU/mg Conforms