Sufentanil Citrate Injection
»Sufentanil Citrate Injection is a sterile solution of Sufentanil Citrate in Water for Injection.It contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of sufentanil citrate (C22H30N2O2S·C6H8O7).
Caution—Handle Sufentanil Citrate Injection with great care since it is a potent opioid analgesic.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification—
A: Ultraviolet Absorption á197Uñ—
Solution: 50µg per mL.
Medium: Use Mobile phaseprepared as directed in the Assay.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 6.25USP Endotoxin Units per mL.
pHá791ñ: between 3.5and 6.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase andChromatographic system— Prepare as directed in the test for Chromatographic purityunder Sufentanil Citrate.
Standard preparation— Dissolve an accurately weighed quantity of USP Sufentanil Citrate RSin water,and dilute quantitatively,and stepwise if necessary,with water to obtain a solution having a known concentration of about 0.075mg per mL.
Assay preparation— Use Sufentanil Citrate Injection.
Procedure— Separately inject equal volumes (about 100µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of sufentanil (C22H30N2O2S)in each mLof the Injection taken by the formula:
386.56/578.69C(rU/rS),
in which 386.56and 578.69are the molecular weights of sufentanil and sufentanil citrate,respectively;Cis the concentration,in mg per mL,of USP Sufentanil Citrate RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1812
Pharmacopeial Forum:Volume No.27(2)Page 2198
Phone Number:1-301-816-8143