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BIVALIRUDIN;BIVALIRUDIN TRIFLUOROACETATE;Bivalirudin, TFA;BITTERMELONP.E;Human Bivalirudin;Bivalirudin Acetate;H-D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu-OH;H-D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu-OH trifluoroacetate salt
Molecular Formula
C98H138N24O33
Molecular Weight
2180.29
Quality Standard
98% up by HPLC, USP, cGMP, DMF
Appearance
white to off-white crystalline powder
COA of Bivalirudin
Items
Specifications
Results
Appearance
White or almost white crystalline powder
White powder
Assay (by HPLC)
98%-102%
99.34%
Identification
Positive
Positive
Absorbance(E1cm)
465-495
482.5
Melting point
191。C - 195。C
93.5。C-195。C
Loss on drying
< 0.5%
0.19%
Specific rotation
+288。-298。
290.2。
Residue on ignition
< 0.10%
0.03%
Related substances
Total related substances < 1.5%
< 1.3%
Single related substances < 0.5%
< 0.4%
Residue solvents
< 0.2%
0.10%
Heavy metals
< 20 ppm
< 10 ppm
Conclusion
Meet the specification of enterprise standard
Usage
Function of Bivalirudin
Bivalirudin is a synthetic anticoagulant. It is an analog of naturally occurring hirudin. It is a polypeptide composed of 20 amino acids. It can bind to thrombin with high affinity and specifically inhibit the activity of thrombin. The reaction catalyzed and induced by thrombin. Bivalirudin can not only bind to free thrombin in plasma, but also bind to thrombin linked to blood clots. This binding is reversible and does not require the presence of ATⅢ. Bivalirudin has a strong anticoagulant effect, and has antithrombotic effect on a variety of animal arterial and venous models. Bivalirudin can prolong partial thromboplastin time (APTT), thrombin time (PT) and activated clotting time (ACT).
Bivalirudin is suitable for patients with unstable angina and unstable angina pectoris undergoing PTCA; percutaneous intervention in acute ischemic coronary complications.
Twenty years of qualification
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