Ritodrine Hydrochloride Injection, chemical structure, molecular formula, Reference Standards

Ritodrine Hydrochloride Injection

»Ritodrine Hydrochloride Injection is a sterile solution of Ritodrine Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C17H21NO3·HCl.

Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.Store at room temperature,preferably below 30

USP Reference standards á11ñ— USP Ritodrine Hydrochloride RS.USP Endotoxin RS.

Identification— The retention time of the ritodrine hydrochloride in the Assay preparationobtained in the Assaycorresponds to that of the Standard preparationobtained in the Assay.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mg.

pHá791ñ: between 4.8and 5.5.

Other requirements— It meets the requirements under Injections á1ñ.

Assay—

Mobile phase,Standard preparation,and System suitability preparation— Proceed as directed in the Assayunder Ritodrine Hydrochloride.

Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 20mg of ritodrine hydrochloride,with Mobile phaseto 100.0mL,and mix.

Chromatographic system— Proceed as directed in the Assayunder Ritodrine Hydrochlorideexcept that the liquid chromatograph is equipped with a 275-nm detector.

Procedure— Proceed as directed in the Assayunder Ritodrine Hydrochloride.Calculate the quantity,in mg,of C17H21NO3·HCl in each mLof the Injection taken by the formula:

(100C/V)(rU/rS),

in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1741

Phone Number:1-301-816-8139