Insights into Dissolution Reporting and Analysis
Explore the comprehensive overview of dissolution reporting, calculations of drug release, and calibration standards. Learn about required fields and sources for accurate analysis in pharmaceutical processes. Discover the significance of cumulative drug release and dissolution profiles in data analysis.
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Presentation Transcript
Dissolution reporting Overview April 4, 2025 1 Dissolution reporting
Dissolution reporting Overview Calculation of the cumulative drug release, cumulative drug release percent, and injection results in Data Analysis: April 4, 2025 Dissolution reporting 2
Dissolution reporting Overview Report includes a summary of the cumulative drug release and a dissolution profile: Example report here: April 4, 2025 Dissolution reporting 3
Dissolution reporting Calculation of the drug release amounts Calculation of the amount in aliquot: ???????? ????????????? ?????? ??????? Cumulative drug release: ? 1 ????.??????? ?????? ??????? ?????? ????? ???????? ????. + ?=1 And cumulative drug release percent: 100 ?????????? ???? ??????? ??????? ?????? ?????? April 4, 2025 Dissolution reporting 4
Dissolution reporting Supported type of calibration Sequence with calibration standards Sequence using a previously saved calibration April 4, 2025 Dissolution reporting 5
Dissolution reporting Required fields and sources Dissolution fields Other fields Capsule Names: Automatic labelling, Sample Name, or any other (customizable). Standard purity: Use of the compound calibration multiplier in the processing method for the standard purity. Dissolution time: Part of the sample name, sample custom field. (not sample description) Target compound in tablet: Fixed amount in custom calculation, sample amount, or compound custom field. Volume aliquot and vessel: Fixed in custom calculation, or sample custom field. April 4, 2025 Dissolution reporting 6
