Five-fold increase in method throughput compared to original method (fifty samples/hour). Associated 10-fold reduction in cost per sample through reduced mobile phase consumption and waste generation. Additional reduced method complexity from easy-to-prepare mobile phase

To demonstrate practical approaches that can be used to significantly improve throughput of the cephradine USP assay monograph keeping to the spirit of USP-NF Chapter <621> guidelines while maintaining USP quality acceptance criteria.

To demonstrate practical approaches that can be used to significantly improve throughput of the ibuprofen USP assay monograph keeping to the spirit o USP-NF Chapter <621> guidelines while maintaining USP quality acceptance criteria. To then take this optimized assay monograph and reduce analysis time even further.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for Assay analysis of Albuterol sulphate as per USP. The analysis was performed on a Thermo Scientific Hypersil Gold CN HPLC column using the method described in the USP 40 monograph. The results obtained for resolution met the criteria as per USP. The results obtained for the resolution between Albuterol sulphate & Albuterol Impurity A was 4.26 (USP criteria is NLT 1.5). RSD for replicate injections were found to be 0.68 & 1.14 forAlbuterol sulphate & Albuterol Impurity A respectively (USP criteria is NLT 1.5%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Amoxicillin and Clavulanate Assay as per USP. The analysis was performed on a Thermo Scientific Syncronis aQ L1 HPLC column using the method described in the USP 40 monograph. The results obtained were found to be within acceptance criteria as stated in the USP. Resolution between Amoxicillin and clavulanic acid was 14.0 (USP criteria: not less than 3.5). Tailing Factors observed were 0.84 & 1.25 respectively (USP criteria: not more than 1.5 for each analyte). RSD found to be less than 2% for both analytes