Abstract: 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.

Abstract: 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 30 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.

Abstract: 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.

Abstract: 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.

Abstract: Provided are a suplatast tosilate crystal showing characteristic peaks in powder X-ray diffraction diffraction angles (20±0.1°) of 5.6°, 9.0°, 11.0°, 15.3°, 16.5°, 17.2°, 17.9°, 19.2°, 19.9°, and 21.5°; and a preparation process of the crystal. Owing to merits such as fluctuation-free optically active substance ratio, low hygroscopicity and high storage stability, the suplatast tosilate crystal of the present invention can be mass-produced easily and, at the same time, is advantageous in drug preparation quality management. It is thus excellent as raw material for pharmaceuticals.

Abstract: Provided are a suplatast tosilate crystal showing characteristic peaks in powder X-ray diffraction at diffraction angles (2&thgr;+0.1°) of 5.6°, 9.0°, 11.0°, 15.3°, 16.5°, 17.2°, 17.9°, 19.2°, 19.9° and 21.5°; and a preparation process of the crystal.