Used in the private or public USP Performance test, dissolution testing plays an important role in both product development and quality assurance for nonsolution oral dosage forms. The dissolution procedure itself, as described in USP General Chapter Dissolution , is sensitive and specific but requires special care in execution. Results of a recent USP collaborative study of new Lot P Prednisone Reference Standard Tablets indicate much higher reproducibility (interlaboratory variance) than repeatability (intralaboratory variance) (1, 2). To improve reproducibility, the USP Biopharmaceutics Expert Committee recommends careful IQ, OQ, and PQ (mechanical calibration), aswellasaPerformanceVerificationTest (PVT); the latter two typically are performed at six-month intervals. Several variables such as shaft rotation speed, shaft and vessel alignment, basket/paddle height, and bath levelness have been cited as factors that contribute to high variability of the dissolution procedure. Missing from this list are factors relating to vessel dimension and irregularities, which are the subject of this report.
Dipl. -Ing. Hans Anthony, ST
He was born in Dabo Singkep, Riau in 1987. He completed his study by receiving his Dipl.-Ing and Bachelor of Engineering Degree in Pharmaceutical Engineering Department from Swiss German University. He was graduated with Cum-laude and his thesis is patent registered with the title 'Production of Pharmaceutical Hard Capsule Shell from Corn Starch'. He was appointed as the Managing Director of PT. Pharma Test Indonesia after finishing a complete training in Pharma Test Headquarter, Germany.
He was born in Sukabumi in 1988. He finished his study in Physical Instrumentation Department of University of Indonesia. Prior to joining PT. Pharma Test Indonesia, he has work experiences in several companies such as PT. Telkom Indonesia and PT. Airfast Indonesia. He has good personality and a hard worker. He joined PT. Pharma Test Indonesia in 2010 and has been attended the training in Pharma Test Headquarter in Germany.