Calcium Lactate Tablets DEFINITION Calcium Lactate Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O). [NoteAn equivalent amount of Calcium Lactate with less water of hydration may be used in place of calcium lactate pentahydrate (C6H10CaO6·5H2O) in preparing Calcium Lactate Tablets. ] IDENTIFICATION • A. Identification TestsGeneral, Calcium 191 Sample solution: A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets Acceptance criteria: Meet the requirements • B. Identification TestsGeneral, Lactate 191 Sample solution: A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets Acceptance criteria: Meet the requirements ASSAY • Procedure Sample: A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 350 mg of calcium lactate pentahydrate (C6H10CaO6·5H2O) Blank: Proceed as directed in the Analysis without the Sample. Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.05 M edetate disodium VS Indicator: Hydroxy naphthol blue, 300 mg Endpoint detection: Visual Analysis: Transfer the Sample to a suitable container, and add 150 mL of water and 2 mL of 3 N hydrochloric acid. Stir, using a magnetic stirrer, for 35 min. While stirring, add 30 mL of Titrant from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Perform a Blank determination. Calculate the percentage of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) in the portion of Tablets taken: Result = {[(VS VB) × M × F ]/W} × 100
Acceptance criteria: 94.0%106.0% PERFORMANCE TESTS • Dissolution, Procedure for a Pooled Sample 711 Medium: Water; 500 mL Apparatus 1: 100 rpm Time: 45 min Analysis: Determine the amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) dissolved, as directed in the Assay, making any necessary modifications. Tolerances: NLT 75% (Q) of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: The quantity of Calcium Lactate stated in the labeling is in terms of calcium lactate pentahydrate. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2458 Pharmacopeial Forum: Volume No. 31(6) Page 1609 |