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| Pramlintide Acetate |
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| medicine and healthy production |
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| 196078-30-5 |
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1 Appearance White slightly yellowish powder White powder
2 Identity 3949.37¡¾2.0 3950.2
3 Solubility Soluble in water or 1% acetic acid conforms
4 Amino Acid Composition ¡¾ 10% conforms
5 Peptide Purity (By HPLC) ¡Ã98% by area integration 98.6%
6 Related Substance(By HPLC) Total Impurities (%)¡Â2.0% Largest Single Impurity (%)¡Â 1.0% 1.4% 0.6%
7 Acetate Content ¡Â15% 9.8%
8 Water Content (Karl Fischer) ¡Â8.0% 4.2%
9 Peptide Content (N determination) ¡Ã80% 85.3%
10 Bacterial Endotoxins ¡Â 50 IU/mg Conforms
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USP31/EP6
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1 Appearance White slightly yellowish powder White powder
2 Identity 3949.37¡¾2.0 3950.2
3 Solubility Soluble in water or 1% acetic acid conforms
4 Amino Acid Composition ¡¾ 10% conforms
5 Peptide Purity (By HPLC) ¡Ã98% by area integration 98.6%
6 Related Substance(By HPLC) Total Impurities (%)¡Â2.0% Largest Single Impurity (%)¡Â 1.0% 1.4% 0.6%
7 Acetate Content ¡Â15% 9.8%
8 Water Content (Karl Fischer) ¡Â8.0% 4.2%
9 Peptide Content (N determination) ¡Ã80% 85.3%
10 Bacterial Endotoxins ¡Â 50 IU/mg Conforms
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pharmaceutical |
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| There are no existing companies to distribute selected chemical product |
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