Eptifibatide Acetate Cas No: 148031-34-9

Characteristic: This product is a white or off-white amorphous powder; odourless and hygroscopic. It is easily soluble in water and almost insoluble in chloroform or acetone; Specific Rotation: Calculated based on anhydrous and acetic acid-free product, the specific rotation is between -52.0 and -56.0; Solution Clarity and Colour: The solution should be clear and colourless. If it is turbid, it should not be darker than the No. 2 turbidity standard solution; if it is coloured, it should not be darker than the yellow No. 1 or yellow-green No. 1 standard colorimetric solution; Acidity: The pH value should be between 3.5 and 5.5; Moisture: Not more than 5.0%; Acetic Acid: Not more than 12.0%; Trifluoroacetic Acid: Not more than 0.5%; Methanol: Not more than 0.3%; Acetonitrile: Not more than 0.041%; N,N-Dimethylformamide: Not more than 0.088%; Asparatic Acid (Asp): 0.8 1.2; Homoarginine (H-HomoArg-OH): 0.8 1.2; Glycine (Gly): 0.8 1.2; Proline (Pro): 0.8 1.2; Tryptophan (Trp): 0.8 1.2; Cysteine (Cys): 0.8 1.2; Related Substances: The peak area of impurity A and impurity H shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution. The peak area of impurity B, impurity C, impurity D and impurity E multiplied by the correction factor (correction factor 1.23), impurity F (correction factor 0.86) and impurity G (correction factor 1.24) shall not be greater than the main peak area of the control solution (0.2%); The peak area of other single unknown impurities shall not be greater than the main peak area of the control solution (0.2%), and the sum of the peak areas of each impurity shall not be greater than 5 times the main peak area of the control solution (1.0%); Polymer: The retention time of each component less than that of eptifibatide impurity G must not exceed 0.5%, and the total impurities should not exceed 1.0% (including impurity G); Arsenic salt: Not more than 0.00015%; Bacterial endotoxins: The amount of endotoxin contained in every 1 mg of eptifibatide should be less than 0.2 EU; Total Aerobic Microbial Count: Not more than 1000 CFU/g; Total Yeasts and Moulds Count: Not more than 100 CFU/g; Bile-tolerant Gram-negative Bacteria; Assay: Calculated as anhydrous and acetic acid-free, this product contains eptifibatide 98.0% 102.0%