Eptifibatide Acetate[CAS:148031-34-9]
Bivalirudin Trifluoroacetate[CAS:128270-60-0]
Product: Eptifibatide Acetate Batch No: 1110002
Manufacturing Date: Oct., 2011 Expiry Date: Oct., 2015
Date of report: Oct., 2011 Quantity: 600 Grams
Items Specifications Results
Appearance: white or off-white powder Complies
Solubility:Soluble in water and 1% acetic acid at a concentration of≥1mg/ml to give a clear,colorless solution Complies
Identification(HPLC):Retention time corresponds to reference standard Complies
Specific Rotation[α]D20: -53.00~-57.00 -53.30
(C=5 in 1% Acetic acid )
Amino Acid Analysis: Complies
Asp:0.95~1.05
Cys: 0.30~1.05
Gly: 0.95~1.05
Pro: 0.95~1.05
Har: 0.95~1.05
Trp: 0.70~1.05
Acetic acid: 10.0%max. 3.41%
Water(K.F.): 5.0%max. 3.65%
Purity(HPLC): 98.5%min. 99.20%
Related substance(HPLC):
Single Impurity: 1.0%max. 0.42%
Total impurity: 1.5%max. 0.80%
Peptide(by N): 85.0%min. 92.3%
Bacterial Endotoxins: 10EU/mg max. Complies
Mass Balance: 95.0~105.0% 100.7%
DMF(GC): 0.088%max. Complies
DCM(GC): 0.06%max. Complies
AcN(GC): 0.041%max. Complies
Mass Spectrum: 831 ~833 Complies
Conclusion:It Complies with the Enterprise’s Standard .
Remarks: Store protected from light,keep dry,cool and dark place.