| | 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) e98% by area integration 98.6%
6 Related Substance( By HPLC) Total Impurities ( % ) d2.0% Largest Single Impurity ( % ) d 1.0% 1.4% 0.6%
7 Acetate Content d15% 9.8%
8 Water Content ( Karl Fischer) d8.0% 4.2%
9 Peptide Content ( N determination) e80% 85.3%
10 Bacterial Endotoxins d 50 IU/ mg Conforms | | |
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