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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±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
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USP31/EP6
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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
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