6National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad, Gandhinagar, Gujarat, India. Questions and Answers Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions. Margareth R. Marques, Ph.D.1 Mark Liddell,...
Pharmacopeia (USP) apparatus 3 can be used as an alternative to USP apparatus 2 for dissolution testing of immediate-release (IR) dosage forms. Highly soluble drugs, metoprolol and ranitidine, and poorly soluble drugs, acyclovir and furosemide, were chosen as model drugs. The dissolution profiles...
TestedAcceptance Criteria S16Average amount dissolved is not less thanQ+ 10%. S26Average amount dissolved (S1+S2) is equal to or greater thanQ+ 5%. S312Average amount dissolved (S1+S2+S3) is equal to or greater thanQ. Extended-Release Dosage Forms ...
711dissolution(USP)..docx,《711》 DISSOLUTION This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. These pharmacopeias have undertaken not to make any unilateral change to this h
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...
The AUC ratio ALB/IS was then tested for linear regression by calculation of the correlation coefficient (R2), and %RSD was then evaluated according to the acceptance criteria of the ICH guidelines. The accuracy and within-run precision were determined by examining six samples with three ...
as a graphical decision-making tool. Theβ-expectation tolerance intervals did not exceed the acceptance criteria of ±10%, which means that 95% of future results will be encompassed in the defined bias limits. The variation of the relative bias ranged between −2.3% and 3.5% and the RSD ...