U.S. PHARMACOPEIA

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Ceftriaxone Injection
» Ceftriaxone Injection is a sterile solution of Ceftriaxone Sodium in a diluent containing one or more tonicity-adjusting agents in Water for Injection. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ceftriaxone (C18H18N8O7S3).
Packaging and storage— Preserve in Containers for Injections as described under Injections 1. Maintain in the frozen state.
Labeling— It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftriaxone, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Bacterial endotoxins 85— It contains not more than 0.20 USP Endotoxin Unit per mg of ceftriaxone.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 6.0 and 8.0.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Ceftriaxone Sodium.
Assay preparation— Allow 1 container of Injection to thaw, and mix. Transfer an accurately measured volume of the Injection, equivalent to about 40 mg of ceftriaxone, to a 200-mL volumetric flask, dilute with Mobile phase to volume, and mix. Use this solution promptly after preparation.
Procedure— Proceed as directed for Procedure in the Assay under Ceftriaxone Sodium. Calculate the quantity, in mg, of ceftriaxone (C18H18N8O7S3) in each mL of the Injection taken by the formula:
200(C / 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 : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 440
Phone Number : 1-301-816-8223