Calcium and Magnesium Carbonates Oral Suspension
Calcium and Magnesium Carbonates Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of calcium carbonate (CaCO3) and NLT 85.0% and NMT 115.0% of the labeled amount of magnesium carbonate (MgCO3).
• A. Identification TestsGeneral, Calcium 191: The addition of 3 N hydrochloric acid to a quantity of Oral Suspension, equivalent to 500 mg of calcium carbonate, produces effervescence, and the resulting solution, after having been filtered, meets the requirements.
• B. Identification TestsGeneral, Magnesium 191
Sample solution: Heat a quantity of Oral Suspension, equivalent to 800 mg of magnesium carbonate, with 20 mL of 1 N sulfuric acid. Cool, add 20 mL of alcohol, mix, and allow to stand for 30 min. Filter this solution, and add 2 mL of 1 N hydrochloric acid to the filtrate.
Acceptance criteria: Meets the requirements
• Calcium Carbonate
Sample solution: Transfer a portion of Oral Suspension equivalent to 400 mg of calcium carbonate, previously well shaken in its original container and free of air bubbles, to a beaker, with the aid of 20 mL of water, and add 10 mL of 1 N hydrochloric acid. Heat on a steam bath for 30 min, allow to cool, transfer with the aid of water to a 100-mL volumetric flask, dilute with water to volume, filter and use the filtrate. [NoteReserve a portion of the filtrate for the Sample solution in the Magnesium Carbonate test. ]
Analysis: Transfer 20.0 mL of Sample solution to a suitable container. Dilute with water to 100 mL, and add 15 mL of 1 N sodium hydroxide, 5 mL of triethanolamine, and 100 mg of hydroxy naphthol blue. Titrate with 0.05 M edetate disodium VS until the solution is deep blue. Each mL of 0.05 M edetate disodium is equivalent to 5.004 mg of CaCO3.
Acceptance criteria: 90.0%110.0%
• Magnesium Carbonate
Sample solution: Use a portion of the filtrate from the Sample solution in the Calcium Carbonate test.
Analysis: Transfer the Sample solution, equivalent to 120 mg of calcium carbonate and magnesium carbonate combined, to a suitable container. Dilute with water to 100 mL, and add 10 mL of ammoniaammonium chloride buffer TS, 5 mL of triethanolamine, and 0.3 mL of eriochrome black TS. Titrate with 0.05 M edetate disodium VS to a blue endpoint. From the volume of 0.05 M edetate disodium consumed, subtract the volume of 0.05 M edetate disodium corresponding to the content of calcium carbonate in the portion of the Sample solution taken. The difference is the volume of 0.05 M edetate disodium equivalent to the quantity of magnesium carbonate present. Each mL of 0.05 M edetate disodium is equivalent to 4.216 mg of MgCO3.
Acceptance criteria: 85.0%115.0%
• Deliverable Volume 698: Meets the requirements
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count is NMT 100 cfu/mL, and it meets the requirements of the tests for absence of Escherichia coli and Pseudomonas aeruginosa.
• pH 791: 7.08.6
• Acid-Neutralizing Capacity 301: NLT 5 mEq of acid is consumed by the minimum single dose recommended in the labeling, and NLT the number of mEq calculated:
Result = [(FM × M) × 0.8] + [(FC × C) × 0.9]
• Packaging and Storage: Preserve in tight containers, and avoid freezing.
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USP35NF30 Page 2448