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.
USP Reference standards 11
USP Ceftriaxone Sodium RS. USP Ceftriaxone Sodium E-Isomer RS. USP Endotoxin RS.
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.
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
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Chromatographic Column
USP32NF27 Page 1862
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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