Eptifibatide acetate USFDA china manufacture 99%min CAS NO.148031-34-9

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