High purity Eptifibatide Injectable Grade with FDA

Details:

Eptifibatide Acetate CAS:148031-34-9 Non Sterile Injectable Grade

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                             -55.86⁰

(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.                   6.3%

Water(K.F.):                      5.0%max.                    5.6%

Purity(HPLC):                     98.5%min.                  99.38%

Related substance(HPLC):

Single Impurity:                   1.0%max.                    0.38%

Total impurity:                     1.5%max.                    0.81%

Peptide(by N):                     85.0%min.                  85.6%

Bacterial Endotoxins:             10EU/mg max.                 Complies

Mass Balance:                    95.0~105.0%                 97.5%

DMF(GC):                        0.088%max.                   0%

DCM(GC):                        0.06%max.                  Complies

AcN(GC):                         0.041%max.                Complies

Mass Spectrum:                   831.5~833.5                  Complies

Conclusion:It Complies with the Enterprise’s Standard .

Remarks: Store protected from light,keep dry,cool and dark place.

 

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