发明名称 Method of evaluating evenness of suplatast tosilate crystal, even crystal, and process for producing the same
摘要 Provided are a method for evaluating evenness of suplatast tosilate crystals; stable suplatast tosilate crystals exhibiting evenness in optical purity; and a method for producing the suplatast tosilate crystals. The method for evaluating evenness of suplatast tosilate crystals includes: (a) a step of adding a solvent to suplatast tosilate crystals to thereby dissolve 3% or less of the crystals in the solvent, and subjecting a portion of the supernatant of the resultant suspension to optical purity measurement, and (b) a step of adding a solvent to the remaining suspension to thereby dissolve the entirety of the suspension in the solvent, and subjecting a portion of the resultant solution to optical purity measurement, wherein the optical purity as measured in the step (a) is compared with the optical purity as measured in the step (b). The suplatast tosilate crystals exhibits excellent evenness and thermal stability. The method for producing the suplatast tosilate crystals is also provided.
申请公布号 US7955607(B2) 申请公布日期 2011.06.07
申请号 US20050632075 申请日期 2005.07.13
申请人 TAIHO PHARMACEUTICAL CO., LTD. 发明人 USHIO TAKANORI;NAGAI KEIKO
分类号 A61K31/164;A61P37/08;C07C233/00;G01N21/84 主分类号 A61K31/164
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