Controlled-release capsules (named brand I and II) containing caffeine, available on the Brazilian and US market as dietary supplements, were assessed following the criteria described by the United States Pharmacopeia. The capsules were evaluated by average weight, caffeine content, disintegration, and...
A Critical Assessment of the USP Dissolution Apparatus Suitability Test Criteria. Drug Dev Ind Phar. 1995;21(8):905-924.Quereshi A., McGilveray J., A critical assessment of the USP dissolution apparatus suitability test criteria, Bureau of Drug Research. 1995, 21:905-924...
A Critical Assessment of the Usp Dissolution Apparatus Suitability Test Criteria evaluation which might yield less variable results with an improved potentials of in vitro/in vivo correlations particularly for modifieddrug release products... SA Qureshi,IJ Mcgilveray - 《Drug Development & Industrial...
J. A critical assessment of the USP dissolution apparatus suitability test criteria. Drug Dev. Ind. Pharm. 21, 905–924 (1995). Article CAS Google Scholar Achanta, A., Gray, V., Cecil, T. & Grady, L. Evaluation of the performance of prednisone and salicylic acid USP dissolution ...
Acceptance Table 2 LevelNumberTestedCriteriaL16No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time.L26The average value of the 12 units (L1 + L2) lies within each of the stated ranges and is not less ...
All dietary supplements belonging to USPClasses IItoVI,prepared as tablets or capsules, are subject to the dissolution test and criteria described in this chapter for folic acid (if present) and for index vitamins and index minerals. This test is required because of the importance of the relation...
TestedCriteria A16No individual value exceeds 10% dissolved. A26Average of the 12 units (A1+A2) is not more than 10% dissolved, and no individual unit is greater than 25% dissolved. A312Average of the 24 units (A1+A2+A3) is not more than 10% dissolved, and no individual unit is gre...
The full list of exclusion and withdrawal criteria is provided in the online Supplementary material. Study Endpoints The primary endpoint of this study was the ratio of the geometric means (90% confidence interval [CI]) for the area under the concentration-time curve (AUC) for Intermediate Aged...
A biowaiver can be granted based on several criteria including solubility or a dose adjusted method. Monensin is practically insoluble in H2O per the USP definition. A comparison was conducted of monensin dissolution profiles from the pioneer product and four generic products using biorelevant media....
(19/9/6) 116 0.17% 102.79 Processes 2021, 9, 176 9 of 22 Based on the characterization of the RLD, the Quality Target Product Profile (QTPP) was elaborated, and also the criteria for the product quality, safety, and efficacy of the targeted formulation were designed (Tables 3 and 4)....