The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the composition and related substances analysis of Colistin Sulfate. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the EP-8.4 monograph. The results obtained for peak resolution met the criteria stated in the EP.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the separation of related impurities of Calcitonin. The separation was performed on a Thermo Scientific Acclaim 120-C18 HPLC column with UV detection at 220 nm. With a total run time of 75 minutes the method allows separation of all related impurities of Calcitonin.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay and organic impurities analysis of minocycline hydrochloride. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution and tailing factor met the criteria stated in the USP 39. The results obtained for resolution between epiminocycline and minocycline was 7.5 (USP criteria of NLT 4.6) and tailing factor of minocycline (0.5 mg/mL) was 0.94 (USP criteria of 0.9 to 2.0).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for assay and early eluting impurities analysis of gabapentin. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 39 monograph. The results obtained for resolution and theoretical plates met the criteria stated in the USP 39. The results obtained for resolution between gabapentin related compound A and gabapentin related compound B was 5.4 (USP criteria of NLT 2.3) and theoretical plates for gabapentin (2.3 mg/mL) was 3660 (USP criteria of minimum 1900).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of sodium lactate. The separation was performed on a Thermo Scientific Acclaim 120-C18 HPLC column with a UV detection at 210 nm.