The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and organic impurities analysis of Tetracycline. The analysis was performed on a Thermo Scientific Acclaim Polar Advantage II C18 HPLC column using the method described in the USP 39 monograph. The results obtained for peak resolution exceed the criteria stated in the USP. Resolution between epitetracycline and tetracycline was 6.5 (USP criteria of NLT 2.5) and anhydrotetracycline and 4-epianhydrotetracycline was 8.7 (USP criteria of NLT 2.5). The tailing for tetracycline was 1.0 (USP criteria of NMT 1.5)

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the organic impurities analysis of Sulfacetamide Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39 monograph. The results obtained for resolution, tailing factor and %RSD met the criteria stated in the USP. The results obtained for resolution between sulfacetamide and sulfanilamide was 21 (USP criteria of NLT 5.0), tailing factor for sulfacetamide was 0.98 (USP criteria of NMT 1.5) and %RSD for sulfacetamide was 1.0% (USP criteria of NMT 2.0%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay analysis of sulfacetamide Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39 monograph. The results obtained for tailing factor and %RSD met the criteria stated in the USP. The results obtained for the tailing factor for sulfacetamide was 0.94 (USP criteria was 0.9 to 1.8) and %RSD for sulfacetamide was 0.1% (USP criteria was NMT 0.5%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of phytonadione. The analysis was performed on a Thermo Scientific Hypersil GOLD Silica HPLC column using the method described in the USP 39 monograph. The results obtained for resolution met the criteria stated in the USP. The results obtained for resolution between the peaks due to (Z)-phytonadione and (E)-phytonadione was 2.1 (USP criteria of NLT 1.5).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and related substances analysis of cefepime hydrochloride. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the USP 39. The results obtained for resolution and tailing factor met the criteria stated in the USP. The results obtained for resolution between the peaks due to cefepime related compound D and cefepime related compound E was 3.7 (USP criteria of NLT 2.0) and tailing factor for cefepime was 1.3(USP criteria of NMT 1.5).