China (Mainland) 
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.