Chloride and sulfate are common impurities present in drug substances and drug products. Current limit tests as per USP general chapter are based on turbidity and/or visual comparison methods. Both methods lack specificity and fail the requirements of data integrity.
Addressing these shortcomings, the USP proposes a selective and sensitive ion chromatography method for chloride and sulfate detection in drug substances, potassium carbonate, and potassium bicarbonate. The method is described in a free technical poster.
One of the main goals of the USP monograph modernization initiative is to replace non-specific methods with highly selective and sensitive instrumental analysis methods. Based on a joint project with Metrohm, the USP proposes a new ion chromatography method for chloride and sulfate detection in drug substances.
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