Dihydroxyaluminum Sodium Carbonate Chewable Tablets
(Monograph under this new title—to become official February 1, 2010)
(Current monograph title is Dihydroxyaluminum Sodium Carbonate Tablets)
» Dihydroxyaluminum Sodium Carbonate Chewable Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of CH2AlNaO5.
Packaging and storage—
Preserve in well-closed containers.
Labeling—
Label the Chewable Tablets to indicate that they are to be chewed before swallowing.
Identification—
A 1 in 10 suspension of powdered Chewable Tablets in 3 N hydrochloric acid meets the requirements of the tests for Aluminum 
191
and for Sodium 191.
191 and for Sodium 191.
Uniformity of dosage units 905:
meet the requirements.
905:
meet the requirements.
Acid-neutralizing capacity 301—
Not less than 5 mEq of acid is consumed by the minimum single dose recommended in the labeling, and not less than the number of mEq calculated by the formula:
301—
Not less than 5 mEq of acid is consumed by the minimum single dose recommended in the labeling, and not less than the number of mEq calculated by the formula:
0.8(0.0278D)
in which 0.0278 is the theoretical acid-neutralizing capacity, in mEq, of CH2AlNaO5, and D is the quantity, in mg, of CH2AlNaO5 in the specimen tested, based on the labeled quantity.
Assay—
Edetate disodium titrant—
Dissolve 18.6 g of edetate disodium in water to make 500 mL, and standardize as directed in the Assay under Ammonium Alum.
Procedure—
Weigh and finely powder not fewer than 20 Chewable Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 300 mg of dihydroxyaluminum sodium carbonate, to a 250-mL beaker, and proceed as directed in the Assay under Dihydroxyaluminum Sodium Carbonate, beginning with “add 10 mL of 2 N sulfuric acid.” Each mL of 0.1 M Edetate disodium titrant is equivalent to 14.40 mg of CH2AlNaO5.
(Official February 1, 2010)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Elena Gonikberg, Ph.D.
Senior Scientist 1-301-816-8251 |
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine |
USP32–NF27 Page 2158
Pharmacopeial Forum: Volume No. 29(6) Page 1873