From Science To Guidance And Practice

This edition covers the pharmaceutical quality spectrum, from topical and semisolid dosage forms, including physico-chemical/microstructural testing and LALA cutaneous product equivalence under the new EMA guideline, to dissolution and drug release testing viewed through both regulatory and compendial lenses. A key thread throughout is automation: how it boosts throughput, efficiency, accuracy, and traceability while cutting costs, as demonstrated by SOTAX systems shift from manual to automated testing.
Closing out the program, JetX™ from SOTAX tackles manual CU and assay sample preparation using patented Jet Xtraction™ technology for fast, gentle API extraction from tablets, capsules, and semi-solids. Offered in SingleFlow (R&D use) and MultiFlow (up to 120 samples per shift, 4x a single analyst's capacity) configurations, it runs the entire workflow unattended, from extraction through dilution and collection. Validation data show results matching manual methods (100.1% vs. 99.9% label claim) in a quarter of the time and with 80% less labor, plus complete digital traceability via AutoDI™ and DataLink™, with no analytical revalidation required.