Abstract: Bivalirudin is used as anticoagulant in patients with coronary artery disease undergoing percutaneous coronary intervention. Also it is safe and cost effective as compared to other anticoagulants which are in use. Bivalirudin is a peptide having 20 amino acids. Related impurities formed during the manufacturing process determine quality of the peptide drugs. These impurities may cause toxicity or change the desired efficacy. ICH guidelines established by regulatory authorities have provided identification threshold for related impurities to ensure purity of.......
Keywords: Bivalirudin, Mass, NMR Spectroscopy, HPLC, Amino acid sequencing, Anticoagulant
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