Aluminum Sulfate and Calcium Acetate Tablets for Topical Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Aluminum Sulfate and Calcium Acetate Tablets for Topical Solution contains NLT 90.0% and NMT 110.0% of the labeled amounts of aluminum sulfate tetradecahydrate [Al2(SO4)3·14H2O] and calcium acetate monohydrate (C4H6CaO4·H2O).
2 IDENTIFICATION
2.1 A. IDENTIFICATION TESTS-GENERAL, Aluminum (191).
Sample solution: Suspend 2 g of ground Tablet powder in 50 mL of water, and filter. Use a portion in the Analysis, and retain the remaining filtrate for Identification test B.
Analysis: Mix 2 mL of the Sample solution with 2 mL of water and 2 drops of 3 N hydrochloric acid.
Acceptance criteria: Meets the requirements of test A
2.2 B. IDENTIFICATION TESTS-GENERAL, Sulfate (191)andCalcium(191).
Sample solution: A portion of the filtrate retained from Identification test A
Acceptance criteria: Meets the requirements
3 ASSAY
3.1 ALUMINUM SULFATE TETRADECAHYDRATE
Sample solution: Finely powder and mix NLT 20 Tablets. Weigh a portion of the powder, equivalent to 2.8 g of aluminum sulfate, and transfer to a 1000-mL volumetric flask. Add 100 mL of 1.2 N hydrochloric acid and 100 mL of water, and heat on a steam bath, with occasional swirling, to dissolve the powder. Allow the solution to cool, and dilute with water to volume. Retain a portion of the Sample solution for the Assay for Calcium Acetate Monohydrate.
Blank: Water
Titrimetric system
Mode: Residual titration
Titrant: 0.02 M zinc sulfate VS
Back-titrant: 0.01 M edetate disodium VS
Endpoint detection: Visual
Analysis: Transfer 25.0 mL of the Sample solution to a 250-mL conical flask. Add, in the order named, 40.0 mL of Back-titrant and 20 mL of acetic acid-ammonium acetate buffer TS, and mix by swirling. Add 50 mL of alcohol and 2 mL of dithizone TS, and titrate the excess Back-titrant with Titrant until the color changes from green-violet to a clear rose-pink. Perform a blank determination. Each mL of 0.01 M edetate disodium is equivalent to 2.972 mg of the labeled amount of aluminum sulfate tetradecahydrate [Al2(SO4)3·14H2O].
Acceptance criteria: 90.0%-110.0%
3.2 CALCIUM ACETATE MONOHYDRATE
Sample: Transfer 20.0 mL of the Sample solution retained from the Assay for Aluminum Sulfate Tetradecahydrate to a 125-mL conical flask.
Titrimetric system
Mode: Direct titration
Titrant: 0.01 M edetate disodium VS
Endpoint detection: Visual
Analysis: With constant stirring, add to the Sample, in the order named, 0.5 mL of trolamine, 10 mL of ammonia-ammonium chloride buffer TS, and 3 drops of a solution prepared by dissolving 500 mg of eriochrome black T trituration in 10 mL of methanol. Titrate with Titrant to a violet endpoint. Each mL of 0.01 M edetate disodium is equivalent to 1.762 mg of the labeled amount of calcium acetate monohydrate (C4H6CaO4·H2O).
Acceptance criteria: 90.0%-110.0%
4 PERFORMANCE TESTS
4.1 DISINTEGRATION (701)
10 min
4.2 UNIFORMITY OF DOSAGE UNITS (905)
Meets the requirements for Weight Variation
5 SPECIFIC TESTS
5.1 PH (791)
Sample solution: 2 g of ground Tablet powder in 500 mL of water
Acceptance criteria: 4.0-4.8
5.2 LOSS ON DRYING (731)
Analysis: Dry ground Tablet powder at 150° for 15 min.
Acceptance criteria: NMT 18%
6 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers, and avoid excessive heat.
