Ferrous Gluconate Tablets DEFINITION Ferrous Gluconate Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of ferrous gluconate dihydrate (C12H22FeO14·2H2O). IDENTIFICATION • A. Thin-Layer Chromatography Standard solution: 10 mg/mL of USP Potassium Gluconate RS Sample solution: A filtered solution in water, equivalent to 10 mg/mL of ferrous gluconate dihydrate from powdered Tablets Chromatographic system Mode: TLC Adsorbent: 0.25-mm layer of chromatographic silica gel Application volume: 5 µL Developing solvent system: Alcohol, ethyl acetate, ammonium hydroxide, and water (50:10:10:30) Spray reagent: Dissolve 2.5 g of ammonium molybdate in 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask. Add 1.0 g of ceric sulfate, swirl to dissolve, and dilute with 2 N sulfuric acid to volume. Analysis Samples: Standard solution and Sample solution Develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110 for 20 min. Allow to cool, and spray with Spray reagent. Heat the plate at 110 for about 10 min. Acceptance criteria: The principal spot of the Sample solution corresponds in color, size, and RF value to that of the Standard solution. • B. Ferrous Ion Sample solution: Equivalent to 5 mg/mL of ferrous gluconate dihydrate from a dilution of the Sample solution obtained in Identification test A Analysis: Add potassium ferricyanide TS to the Sample solution. Acceptance criteria: The solution yields a dark blue precipitate. ASSAY • Procedure Sample: A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 1.5 g of ferrous gluconate dihydrate Blank: Proceed as directed in the Analysis without the Sample. Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.1 N ceric sulfate VS Indicator: Orthophenanthroline TS Endpoint detection: Visual Analysis: Dissolve the Sample in a mixture of 75 mL of water and 15 mL of 2 N sulfuric acid in a 300-mL conical flask. Add 250 mg of zinc dust, close the flask with a stopper containing a Bunsen valve, and allow to stand at room temperature for 20 min or until the solution becomes colorless. Pass the solution through a filtering crucible containing a thin layer of zinc dust, and wash the crucible and contents with 10 mL of 2 N sulfuric acid, followed by 10 mL of water. [NotePrepare and use the filtering crucible in a well-ventilated hood. ] Add orthophenanthroline TS, and immediately titrate the filtrate in the suction flask with Titrant until color change. Perform a Blank determination. Calculate the percentage of the labeled amount of ferrous gluconate dihydrate (C12H22FeO14·2H2O) in the portion of Tablets taken: Result = {[(VS VB) × N × F]/W} × 100
Acceptance criteria: 93.0%107.0% PERFORMANCE TESTS • Dissolution 711 Medium: Simulated gastric fluid TS; 900 mL Apparatus 2: 150 rpm Time: 80 min Standard solution: Solution having a known concentration of iron in the Medium Sample solution: Filtered portion of the solution under test, suitably diluted with the Medium if necessary Instrumental conditions Mode: Atomic absorption spectrophotometry Analytical wavelength: 248.3 nm Lamp: Iron hollow-cathode Flame: Airacetylene Analysis Samples: Standard solution and Sample solution Determine the concentration of iron (Fe) in the Sample solution in comparison with a Standard solution. Calculate the percentage of the labeled amount of ferrous gluconate dihydrate (C12H22FeO14·2H2O) dissolved: Result = (Mr/Ar) × (C × D × V/L) × 100
Tolerances: NLT 80% (Q) of the labeled amount of ferrous gluconate dihydrate (C12H22FeO14·2H2O) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: Label the Tablets in terms of the content of ferrous gluconate dihydrate (C12H22FeO14·2H2O) and in terms of the content of elemental iron. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3178 |