USP Dissolution Calibrators: Re-examination and …

6 DissolutionTechnologies| FEBRUARY 2005As part of an oral drug product specification, dissolutiontesting is exceptional in that it assesses performancefrom a number of perspectives. This type of testingprovides the formulator a range of indications from thesummative quality of their product manufacturing processesto a surrogate assessment of potential in-vivo performanceduring the product s lifetime. Calibration of Dissolution appa-ratuses is simply a demonstration of suitability for use in thattest and, in concept, is similar to system suitability determina-tions for other analytical procedures. Dissolution perfor-mance is measured by the rate of appearance of the drug insolution and many other variables are at work to produce anobserved Dissolution rate. In the Dissolution test the USPapparatus is merely the operational equipment source of thesample. The use of a standard tablet in Dissolution apparatuscalibration allows verification that the sample produced isrepresentative of what might be considered best providing standard calibrator tablets, the USP acceptsresponsibility for reproducible performance of the calibra-tors and for setting appropriate criteria for calibration.

Dissolution Technologies| FEBRUARY 2005 7 speed,the data is subjected to a nested random effects model statistical method and the variance components from inter-laboratory,intra-laboratory,and inter-tablet sources are

Loading..

Tags:

  Data, Course, Examination, Dissolution, Calibrator, Usp dissolution calibrators, Re examination and

Information

Related search queries