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| Bivalirudin Acetate |
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| medcine and healthy production |
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| 128270-60-0 |
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1 Appearance White powder White powder
2 Identity 2180.29±1.0 2180.7
3 Specific Optical Rotation (c=0.5,1%HAc) -100～-120.0° -115°
4 Amino Acid Composition ± 10% Conforms
5 Peptide Purity (By HPLC) ≥98% by area integration 98.8%
6 Related Substance (By HPLC) Total Impurities (%)≤2.0% Largest Single Impurity (%)≤ 1.0% 1.2% 0.5%
7 Acetate Content (By HPLC) ≤15% 11.2%
8 Water Content (Karl Fischer) ≤6.0% 4.8%
9 Bacterial Endotoxins ≤15 EU/mg Conforms
10 Peptide Content (N determination) ≥80% 83.6%
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USP31/EP
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1 Appearance White powder White powder
2 Identity 2180.29±1.0 2180.7
3 Specific Optical Rotation (c=0.5,1%HAc) -100～-120.0° -115°
4 Amino Acid Composition ± 10% Conforms
5 Peptide Purity (By HPLC) ≥98% by area integration 98.8%
6 Related Substance (By HPLC) Total Impurities (%)≤2.0% Largest Single Impurity (%)≤ 1.0% 1.2% 0.5%
7 Acetate Content (By HPLC) ≤15% 11.2%
8 Water Content (Karl Fischer) ≤6.0% 4.8%
9 Bacterial Endotoxins ≤15 EU/mg Conforms
10 Peptide Content (N determination) ≥80% 83.6%
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