Potassium Gluconate Tablets
DEFINITION
Potassium Gluconate Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of potassium gluconate (C6H11KO7).
IDENTIFICATION
• A. Infrared Absorption 
197M
: The IR absorption spectrum of potassium gluconate extracted from finely powdered Tablets exhibits maxima only at the same wavelengths as that of a similar preparation of USP Potassium Gluconate RS.
197M: The IR absorption spectrum of potassium gluconate extracted from finely powdered Tablets exhibits maxima only at the same wavelengths as that of a similar preparation of USP Potassium Gluconate RS.• B. Identification Tests—General, Potassium 191
191 Sample solution: Triturate a portion of powdered Tablets with a few mL of water, and filter.
Acceptance criteria: The filtrate meets the requirements of the flame test.
ASSAY
• Procedure
Standard stock solution: 19.07 µg/mL of potassium chloride in water (equivalent to 10 µg/mL of potassium), prepared from potassium chloride previously dried at 105
for 2 h
for 2 hStandard solutions: 1.0, 1.5, and 2.0 µg/mL of potassium from suitably diluted Standard stock solution in a solution containing 4 mg/mL of sodium chloride and 1 mL of hydrochloric acid per 100 mL
Sample stock solution: Filtered water solution containing 0.18 mg/mL of potassium gluconate from NLT 20 finely powdered Tablets.
Sample solution: Transfer 5.0 mL of Sample stock solution to a 100-mL volumetric flask. Add 2.0 mL of a 200-mg/mL sodium chloride solution and 1.0 mL hydrochloric acid, and dilute with water to volume.
Blank: Water
Instrumental conditions
Mode: Atomic absorption spectrophotometry
Analytical wavelength: 766.5 nm
Lamp: Potassium hollow-cathode
Flame: Air–acetylene
Analysis
Samples: Standard solutions and Sample solution
Determine the absorbances of the Standard solutions and the Sample solution. Plot the absorbance of the Standard solutions versus their concentrations, in µg/mL, of potassium, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, C, in µg/mL, of potassium in the Sample solution.
Calculate the percentage of the labeled amount of potassium gluconate (C6H11KO7) in the portion of Tablets taken:
Result = (C/CU) × (Mr/Ar) × 100
| C | = | = determined concentration of potassium in the Sample solution (µg/mL) |
| CU | = | = nominal concentration of potassium gluconate in the Sample solution (µg/mL) |
| Mr | = | = molecular weight of potassium gluconate, 234.25 |
| Ar | = | = atomic weight of potassium, 39.10 |
Acceptance criteria: 95.0%–105.0%
PERFORMANCE TESTS
• Dissolution 711
711 Medium: Water; 900 mL
Apparatus 2: 100 rpm
Time: 45 min
Sample solution: Filtered portion of the solution under test, suitably diluted with Medium if necessary
Analysis: Proceed as directed in the Assay.
Calculate the percentage of the labeled amount of potassium gluconate (C6H11KO7) dissolved:
Result = (C × D × V/L) × (Mr/Ar) × 100
| C | = | = determined concentration of potassium in the Sample solution (mg/mL) |
| D | = | = dilution factor for the Sample solution |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim (mg/Tablet) |
| Mr | = | = molecular weight of potassium gluconate, 234.25 |
| Ar | = | = atomic weight of potassium, 39.10 |
Tolerances: NLT 75% (Q) of the labeled amount of potassium gluconate (C6H11KO7) is dissolved.
• Uniformity of Dosage Units 905: Meet the requirements
905: Meet the requirementsADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in tight containers.
• USP Reference Standards 11
11 USP Potassium Gluconate RS 
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Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova Scientific Liaison 1-301-816-8328 | (DS2010) Monographs - Dietary Supplements |
| 711 | Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106 | (GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4369