FIELD: technology of medicines production.
SUBSTANCE: method includes assessment of appearance, measurement of average mass of suppositories in the process of storage, determination of deviation value from average mass, melt temperature by means of comparison with initial values of investigated parameters that comply with technological instruction for this product, at that additionally freezing temperature is assessed, as well as difference value between melt and freezing temperatures, time of full deformation, dynamics of pantogamum release from suppositories, and also value of efficient viscosity, which is measured after beginning of load application at temperature of 37.0°C and 42.0°C, rate of shift from 5.4 c-1 to 145.8 c-1 or from 145.8 c-1 to 5.4 c-1, and inspection takes place on 90th, 180th and 360th days of storage.
EFFECT: invention provides simplification of method, increase of accuracy and efficiency of suppositories quality control in the process of storage.
3 ex, 6 dwg
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Authors
Dates
2008-07-27—Published
2006-09-21—Filed