Aluminum Acetate 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 Acetate Topical Solution yields NLT 1.20 g and NMT 1.45 g of aluminum oxide (Al2O3) and NLT 4.24 g and NMT 5.12 g of acetic acid (C2H4O2), corresponding to NLT 4.8 g and NMT 5.8 g of aluminum acetate (C6H9AlO6) in each 100 mL. Aluminum Acetate Topical Solution may be stabilized by the addition of NMT 0.6% of boric acid (H3BO3).
Aluminum Subacetate Topical Solution | 545 mL |
Glacial Acetic Acid | 15 mL |
Purified Water, a sufficient quantity to make | 1000 mL |
Add the Glacial Acetic Acid to the Aluminum Subacetate Topical Solution and sufficient Purified Water to bring to nal volume. Mix, and filter if necessary. Dispense only clear Aluminum Acetate Topical Solution.
2 IDENTIFICATION
A. Identification Tests—General 〈191〉: It meets the requirements of the test for Aluminum and for the test B under Acetate. Ferric chloride TS produces a deep red color that is destroyed by the addition of a mineral acid.
3 ASSAY
3.1 Aluminum Oxide
Edetate disodium titrant: Prepare and standardize 0.05 M edetate disodium titrant as directed in Reagents, Volumetric Solutions, Edetate Disodium, Twentieth-Molar (0.05 M).
Sample: 25 mL
Blank: 25 mL of water
Titrimetric system
Mode: Residual titration
Back-titrant: 0.05 M zinc sulfate VS
Endpoint detection: Visual
Analysis: Pipet the Sample into a 250-mL volumetric ask, add 5 mL of hydrochloric acid, and dilute with water to volume. Pipet 25 mL of this solution into a 250-mL beaker, and add, in the order named and with continuous stirring, 25.0 mL of Edetate disodium titrant and 20 mL of acetic acid–ammonium acetate buffer TS, then heat the solution near the boiling point for 5 min. Cool, and add 50 mL of alcohol and 2 mL of dithizone TS. Titrate the solution with Back-titrant to a bright rose-pink color. Perform a blank determination, and make any necessary correction. Each mL of Edetate disodium titrant is equivalent to 2.549 mg of aluminum oxide (Al2O3).
Acceptance criteria: 1.20–1.45 g of aluminum oxide (Al2O3) in 100 mL
4 Acetic Acid
Sample: 20 mL
Titrimetric system
Mode: Residual titration
Titrant: 0.5 N sodium hydroxide VS
Back-titrant: 0.5 N sulfuric acid VS
Endpoint detection: Visual
Analysis: Pipet the Sample into a Kjeldahl ask containing a mixture of 20 mL of phosphoric acid and 150 mL of water. Connect the ask to a condenser, the delivery tube from which dips beneath the surface of 50.0 mL of Titrant contained in a receiving ask. Distill about 160 mL, then remove the delivery tube from below the surface of the liquid. Allow the distilling ask to cool, add 50 mL of water, and distill an additional 40–45 mL into the receiving ask. Add phenolphthalein TS to the distillate, and titrate the excess Titrant with Back-titrant. Each mL of Titrant is equivalent to 30.03 mg of acetic acid (C2H4O2).
Acceptance criteria: 4.24–5.12 g of acetic acid (C2H4O2) in 100 mL
5 OTHER COMPONENTS
5.1 Limit of Boric Acid
Sample: 25 mL
Titrimetric system
Mode: Direct titration
Titrant: 0.5 N sodium hydroxide VS
Endpoint detection: Visual
Analysis: Pipet the Sample into 75 mL of water in a conical ask. Add 3 mL of phenolphthalein TS, and add Titrant from a buret until a faint pink color is obtained. Heat to boiling, and again neutralize. Add 150 mL of Glycerin to the neutralized solution, and titrate with Titrant. Perform a blank determination in a similar manner. Subtract the volume of Titrant used in the blank from the volume of Titrant used after the addition of the glycerin. Each mL of Titrant is equivalent to 30.92 mg of boric acid (H3BO3).
Acceptance criteria: NMT 0.6% of boric acid (H3BO3)
6 IMPURITIES
7 SPECIFIC TESTS
pH 〈791〉: 3.6–4.4
8 ADDITIONAL REQUIREMENTS
Packaging and Storage: Package in tight containers.
