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Modernization of USP and Ph. Eur. Method – Pantoprazole Sodium Sesquihydrate Organic Impurities (TN-1327)
In this technical note, the fully porous Luna™ 5 µm C18(2), 125 x 4.0 mm (specified dimensions as per the monograph) column was used for the analysis of Pantoprazole. Further, modernization of this method was carried out on a fully porous, thermally modified, Luna Omega 3 µm C18, 100 x 3.0 mm column and a fully porous organo-silica Gemini™ 3 µm NX-C18, 100 x 3 mm column by scaling down the method to current column dimensions and the method has been verified with adjusted flow rate (rounding off to single decimal point) and gradient within the adjustments of chromatographic conditions allowed per USP and Ph. Eur. for gradient methods (Table 1).
Modernization of USP and Ph. Eur. Method – Pantoprazole Sodium Sesquihydrate Organic Impurities (TN-1327)
In this technical note, the fully porous Luna™ 5 µm C18(2), 125 x 4.0 mm (specified dimensions as per the monograph) column was used for the analysis of Pantoprazole. Further, modernization of this method was carried out on a fully porous, thermally modified, Luna Omega 3 µm C18, 100 x 3.0 mm column and a fully porous organo-silica Gemini™ 3 µm NX-C18, 100 x 3 mm column by scaling down the method to current column dimensions and the method has been verified with adjusted flow rate (rounding off to single decimal point) and gradient within the adjustments of chromatographic conditions allowed per USP and Ph. Eur. for gradient methods (Table 1).
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