U.S. PHARMACOPEIA

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Ritodrine Hydrochloride Injection
» Ritodrine Hydrochloride Injection is a sterile solution of Ritodrine Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C17H21NO3·HCl.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass. Store at room temperature, preferably below 30.
Identification— The retention time of the ritodrine hydrochloride in the Assay preparation obtained in the Assay corresponds to that of the Standard preparation obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mg.
pH 791: between 4.8 and 5.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase, Standard preparation, and System suitability preparation— Proceed as directed in the Assay under Ritodrine Hydrochloride.
Assay preparation— Dilute an accurately measured volume of Injection, equivalent to about 20 mg of ritodrine hydrochloride, with Mobile phase to 100.0 mL, and mix.
Chromatographic system— Proceed as directed in the Assay under Ritodrine Hydrochloride except that the liquid chromatograph is equipped with a 275-nm detector.
Procedure— Proceed as directed in the Assay under Ritodrine Hydrochloride. Calculate the quantity, in mg, of C17H21NO3·HCl in each mL of the Injection taken by the formula:
(100C / V)(rU / rS),
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1932
Phone Number : 1-301-816-8143