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| Exenatide Acetate |
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| pharmaceutical |
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| 141732-76-5 |
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Molecular Formula C184H282N50O60S
Molecular Weight 4186.6
1 Appearance White powder White powder
2 Solubility Soluble in water or 1% acetic acid at a concentration of 1mg/ml Conforms
3 Amino Acid Composition ±10% of theoretical Conforms
4 Peptide Purity (By HPLC) ≥ 98.0% by area integration 99.1%
5 Related Substance (By HPLC) Total Impurities(%) ≤ 2.0% 0.9%
6 Peptide Content(N determination) ≥ 80.0% 84.6%
7 Acetate Content ≤ 15.0% 10.2%
8 Water Content (Karl Fischer) ≤ 6.0% 4.8%
9 Bacterial Endotoxins ≤5EU/mg Conforms
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USP31/EP6
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Molecular Formula C184H282N50O60S
Molecular Weight 4186.6
1 Appearance White powder White powder
2 Solubility Soluble in water or 1% acetic acid at a concentration of 1mg/ml Conforms
3 Amino Acid Composition ±10% of theoretical Conforms
4 Peptide Purity (By HPLC) ≥ 98.0% by area integration 99.1%
5 Related Substance (By HPLC) Total Impurities(%) ≤ 2.0% 0.9%
6 Peptide Content(N determination) ≥ 80.0% 84.6%
7 Acetate Content ≤ 15.0% 10.2%
8 Water Content (Karl Fischer) ≤ 6.0% 4.8%
9 Bacterial Endotoxins ≤5EU/mg Conforms
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