|
Aluminum Hydroxide Gel
Al(OH)3
Aluminum hydroxide. Aluminum hydroxide » Aluminum Hydroxide Gel is a suspension of amorphous aluminum hydroxide in which there is a partial substitution of carbonate for hydroxide. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of aluminum hydroxide [Al(OH)3]. It may contain Peppermint Oil, Glycerin, Sorbitol, Sucrose, Saccharin, or other suitable flavors, and it may contain suitable antimicrobial agents.
Packaging and storage
Preserve in tight containers, and avoid freezing.
Identification
A:
Place about 1 g in a flask equipped with a stopper and glass tubing, the tip of which is immersed in calcium hydroxide TS in a test tube. Add 5 mL of 3 N hydrochloric acid to the flask, and immediately insert the stopper: gas evolves in the flask and a precipitate is formed in the test tube.
B:
The solution remaining in the flask responds to the tests for Aluminum
Microbial enumeration tests
Acid-neutralizing capacity
pH
Chloride
Transfer an accurately measured quantity of the Gel, equivalent to 0.6 g of Al(OH)3, to a porcelain dish. Add 0.1 mL of potassium chromate TS and 25 mL of water. Stir, and add 0.10 N silver nitrate until a faint, persistent pink color is obtained: not more than 8.0 mL of 0.10 N silver nitrate is required [4.7%, based on the Al(OH)3 content].
Sulfate
Arsenic, Method I
Heavy metals
Assay
Procedure
Transfer an accurately measured quantity of Gel, equivalent to about 1.5 g of Al(OH)3, to a beaker, add 15 mL of hydrochloric acid, and heat gently until solution is complete. Cool, transfer to a 500-mL volumetric flask, dilute with water to volume, and mix. Pipet 20 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 acidammonium acetate buffer TS, then heat the solution near the boiling point for 5 minutes. Cool, and add 50 mL of alcohol and 2 mL of dithizone TS. Titrate the solution with 0.05 M zinc sulfate VS until the color changes from green-violet to rose-pink. Perform a blank determination, substituting 20 mL of water for the sample, and make any necessary correction. Each mL of 0.05 M Edetate disodium titrant consumed is equivalent to 3.900 mg of Al(OH)3.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1483
|