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PROCESS FOR PREPARING STABLE PHARMACEUTICAL COMPOSITIONS OF COMPOUNDS SUSCEPTIBLE TO HYDROLYSIS
专利权人:
发明人:
申请号:
EP12719066.8
公开号:
EP2811984A1
申请日:
2012.03.29
申请国别(地区):
EP
年份:
2014
代理人:
摘要:
The present invention relates to a process of preparing a stable pharmaceutical composition of compounds which are susceptible to hydrolysis comprising a. Addition of required quantity of pharmaceutically acceptable lyophilization excipients optionally in Water for Injection in a formulation vessel b. Addition of organic solvent to form a appropriate proportion of aqueous and organic solvent c. Maintaining the temperature of the formulation vessel from the range −5±1° C. to −5±3° C. d. Addition of required quantity of compound susceptible to hydrolysis to form a solution and lyophilizing the solution.
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