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.
USP Reference standards 11
USP Ritodrine Hydrochloride RS Click to View Structure
USP Endotoxin RS
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.
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.
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Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
1-301-816-8124
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4578