Product Info.
 
Bivalirudin Acetate
CAS No. 128270-60-0
Molecular Formula C98H138N24O33
Molecular Weight 2180.29
Storage 2~8℃
Batch No. 20070518
Manufacturing Date 2007-05-18
Retest Date 2009-05-18
Sequence
TEST ITEMS SPECIFICATION RESULT
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%