프렌켈, 앤톤,랙서, 아비탈,이오페, 블라디미르,얀손, 칼-에릭,프리스테드트, 울프, 토마스
申请号：
KR1020157029570
公开号：
KR1020150143499A
申请日:
2014.03.14
申请国别(地区):
KR
年份:
2015
代理人:
摘要：
The present invention relates to a process for the preparation of (a) a process for the preparation of a pharmaceutical composition comprising the steps of: (i) having a size of? 90% of the total volume of raucuni mode sodium particles of? 40 microns； or (ii)? 50% of the total volume of raquinimodal sodium particles of? 15 microns Wherein the mixture has a bulk density of from 0.2 g / mL to 0.4 g / mL； b) said mixture has a tap density of 0.40 g / mL to 0.7 g / mL； c) the amount of heavy metal in the mixture is not more than 20 ppm based on the weight of sodium rasuni mode； d) the amount of MCQ in the mixture is not more than 0.15% based on the amount of sodium raximumime as determined by HPLC； e) the amount of MCQCA in said mixture is not more than 0.15% based on the amount of sodium laximumimide as determined by HPLC； Or f) the amount of MCQME present in the mixture is less than or equal to 0.12% based on the amount of sodium rasuniimide as determined by HPLC. The present invention also provides a pharmaceutical composition comprising an amount of at least one of Racoony mode and BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE. The present invention also provides a method of producing BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, and compounds produced by the method. Also provided is a method for testing whether a lacquer mode sample contains undesirable impurities. Also provided is a method for the production of an identified pharmaceutical composition comprising a rquinimy mode or a method for the manufacture of a pharmaceutical composition comprising a ricinyi mode or a method for the production of an identified batch of a pharmaceutical composition comprising a ricinyi mode, There is provided a method for identifying a batch of a pharmaceutical composition comprising a pharmaceutically acceptable carrier for rquishnime mode and distribution and a method for preparing a packaged pharmaceutical composition comprising a rquinimode mode, Determining the amount of at least one
