The monograph below became official on February 1, 2022.

According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 45(4)*), "ASSAY Procedure 1: Potassium Bicarbonate and Sodium Bicarbonate" for "Potassium and Sodium Bicarbonates and Citric Acid Effervescent Tablets for Oral Solution" should be carried out with a column filled with L76 packing material. The IC YK-421, a column filled with L76 packing material, confirmed the requirements were met.

System suitability requirements Resolution between sodium and ammonium peaks (System suitability solution): ≥ 2.0
Tailing factor for sodium and potassium peaks (Standard solution): ≤ 2.0
Relative standard deviation (RSD) for sodium and potassium peaks (Standard solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 20 μL
(System suitability solution) 30 µg/mL each of Sodium bicarbonate and Ammonium chloride in water

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Sample: 20 μL
(Standard solution) 10 µg/mL of Potassium bicarbonate and 30 µg/mL of Sodium bicarbonate in water

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