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Aminohippurate Sodium Injection
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C9H9N2NaO3 216.17

Glycine, N-(4-aminobenzoyl)-, monosodium salt.
Monosodium p-aminohippurate [94-16-6].
» Aminohippurate Sodium Injection is a sterile solution of Aminohippuric Acid in Water for Injection prepared with the aid of Sodium Hydroxide. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C9H9N2NaO3.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Identification—
A: A volume of Injection, equivalent to 100 mg of aminohippuric acid, diluted to 50 mL and acidified with hydrochloric acid, responds to Identification test B under Aminohippuric Acid.
B: Transfer a volume of Injection, equivalent to about 200 mg of aminohippurate sodium, to a test tube, and add, in the order named, 2 mL of potassium iodide TS, 10 mL of water, and 5 mL of sodium hypochlorite TS: a red color is produced.
C: It responds to the flame test for Sodium 191.
Bacterial endotoxins 85— It contains not more than 0.04 USP Endotoxin Unit per mg of aminohippurate sodium.
pH 791: between 6.7 and 7.6.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer to a 200-mL volumetric flask an accurately measured volume of Injection, equivalent to about 1 g of aminohippurate sodium, and dilute with water to volume. Transfer 50.0 mL of the solution to a suitable container, add 5 mL of hydrochloric acid, and proceed as directed under Nitrite Titration 451, beginning with “cool to about 15.” Each mL of 0.1 M sodium nitrite is equivalent to 21.62 mg of C9H9N2NaO3.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 138
Phone Number : 1-301-816-8385