Eptifibatide acetate USFDA china manufacture 99%min

Eptifibatide

Eptifibatide acetate

peptide

≥99.0% It conforms USFDA standard

 




Appearance



White or almost white powder





Solubility



Freely soluble in 1% acetic acid,soluble in water





Identification

 



A. The IR spectrum obtained from sample corresponds to that obtained from Eptifibatide RS





 



B. The retention time of major peak in the chromatogram obtained from test solution corresponds to that in the chromatogram obtained from reference solution，as obtained in the assay.





Clarity and color of solution



It is clear and colorless





PH



3.5~5.5





Water 



≤5.0%





Specific Rotation



-52°~ -57 º calculated on anhydrous and acetic acid-free basis





Trifluoroacetic acid



Trifluoroacetic acid ≤2.0%





Acetic acid 



Acetic acid ≤10.0%





Related substances



Impurity B ≤0.5%





 



Impurity A ≤0.5%

Impurity C ≤0.5%

Any other impurity: ≤0.2%

Total impurities (except impurity A& impurity C): ≤0.5%





Ratio of amino acid



Asp: 0.85~1.15

Homo: 0.85~1.15

Gly: 0.85~1.15

Pro: 0.85~1.15

Cys: 0.75~1.15

Trp：present 





Assay 



95.0%~105.0% calculated on anhydrous and acetic acid-free basis 





Microbiological 

Examination 



TAMC:≤50cfu/g

TYMC:≤20cfu/g

Escherichia.coli:absent

Staphylococcus aureus:absent

Pseudomonas aeruginosa:absent

Salmonella : absent





Bacterial endotoxins



≤0.25EU/mg





Heavy metals



≤20ppm





Residual solvents




Methanol:≤3000ppm

Ethanol:≤5000ppm

Ether:≤5000ppm

Acetonitrile:≤410ppm

Dichloromethane:≤600ppm

TIS:≤50ppm

DMF:≤880ppm

Benzene:≤2ppm