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.
• B. Identification TestsGeneral, Potassium 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
Standard 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:
Airacetylene
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
Acceptance criteria:
95.0%105.0%
PERFORMANCE TESTS
• Dissolution 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
Tolerances:
NLT 75% (Q) of the labeled amount of potassium gluconate (C6H11KO7) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4369
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