U.S. PHARMACOPEIA

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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 90.0 percent and not more than 110.0 percent of the labeled amount of sufentanil citrate (C22H30N2O2S·C6H8O7).
Caution—Handle Sufentanil Citrate Injection with great care, as it is a potent opioid analgesic.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Identification—
A: Ultraviolet Absorption 197U—
Solution: 50 µg per mL.
Medium: Use Mobile phase prepared as directed in the Assay. [NOTE—For samples that do not require dilution to achieve 50 µg per mL, use Water for Injection as the medium for the Standard solution.]
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 6.25 USP Endotoxin Units per mL.
pH 791: between 3.5 and 6.0.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase and Chromatographic system— Prepare as directed in the test for Chromatographic purity under Sufentanil Citrate.
Standard preparation— Dissolve an accurately weighed quantity of USP Sufentanil Citrate RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about 0.075 mg per mL.
Assay preparation— Use Sufentanil Citrate Injection.
Procedure— Separately inject equal volumes (about 100 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of sufentanil (C22H30N2O2S) in each mL of the Injection taken by the formula:
386.56 / 578.69C(rU / rS),
in which 386.56 and 578.69 are the molecular weights of sufentanil and sufentanil citrate, respectively; C is the concentration, in mg per mL, of USP Sufentanil Citrate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 2016
Pharmacopeial Forum : Volume No. 30(6) Page 2045
Phone Number : 1-301-816-8139