Calcium Lactate Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Calcium Lactate Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of calcium lactate pentahydrate (C₆H₁₀CaO₆ .5H₂O).

[NOTE-An 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.]

2 IDENTIFICATION

2.1 A. IDENTIFICATION TESTS GENERAL, Calcium (191)

Sample solution: A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets

Acceptance criteria: Meet the requirements

2.2 B. IDENTIFICATION TESTS-GENERAL, Lactate(191)

Sample solution: A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets

Acceptance criteria: Meet the requirements

3 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 3-5 min. While stirring, add 15 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 = {[(V_S-V_B)×M×F]/W)×100

V_S = Titrant volume consumed by the Sample (mL)

V_B = Titrant volume consumed by the Blank (mL)

M = actual molarity of the Titrant (mM/mL)

F = equivalency factor, 308.4 (mg/mM)

W = nominal weight of calcium lactate pentahydrate in the Sample taken (mg)

Acceptance criteria: 94.0%-106.0%

4 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

5 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.