Aminohippurate Sodium Injection
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.
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
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1520
|