作者: Choksi Pranavkumar Jayesh , Patel Mitesh Natavarlal , Dave Mafatlal Tribhovandas , Anklesaria Beena Pourusashap
DOI:
关键词: Hydrochloride 、 Chemistry 、 Stabilizer (chemistry) 、 Chromatography 、 Dalbavancin
摘要: A lyophilized pharmaceutical composition comprising: a) dalbavancin hydrochloride or its pharmaceutically acceptable salt; b) a amount of amino acid as stabilizer) the ratio dalvabancin to stabilizer is 1:0.8 1:1 by weight, d) said formulation has pH in range 5.1-6 v) contains no more than about 1% MAG weight after 3 Months at 40°C and 75 % RH.