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Displaying 1-3 of 3 results for Tag: KP X monograph

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Related substances analysis of cefepime dihydrochloride hydrate using a C18 HPLC column as per JP XVI and KP X monograph method

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the related substances analysis of cefepime dihydrochloride hydrate. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the JP XVI and KP X. The results obtained for theoretical plates and %RSD for cefepime met the criteria stated in the JP/KP monograph. The results obtained for theoretical plates of cefepime was 54,132 (JP/KP criteria of not less than 6,000) and %RSD for cefepime was 0.1% (JP/KP criteria of not more than 2).

Assay and related substances analysis of flucloxacillin using a C18 HPLC column using the EP 8.0 and KP X monograph method.

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay and related substances analysis of Flucloxacillin. The analysis was performed on a Thermo Scientific Hypersil GOLD aQ HPLC column using the method described in the EP 8.0 and KP X. The results obtained for resolution and % RSD met the criteria stated in the EP and KP. The results obtained for resolution between the peaks due to Cloxacillin and Flucloxacillin was 5.9 (EP and KP criteria of minimum 2.5) and %RSD for flucloxacillin (0.1 mg/mL) was 0.1 (EP & KP criteria of maximum 1).

Assay and related substances analysis of Cefotaxime sodium using a C18 HPLC column as per JP XVI and KP X monograph methods

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay and related substances analysis of Cefotaxime Sodium. The analysis was performed on a Thermo Scientific Syncronis aQ HPLC column using the method described in the JP XVI/KP X. The results obtained for resolution and symmetry factor met the criteria stated in the JP/KP. The results obtained for resolution between the peaks due to desacetyl Cefotaxime and Cefotaxime was 32.8(JP/KP criteria of minimum 20.0) and symmetry factor for cefotaxime was 1.0 (JP/KP criteria of maximum 2).