Cefuroxime Injection
» Cefuroxime Injection is a sterile isoosmotic solution of Cefuroxime Sodium in Water for Injection. It contains one or more suitable buffers and a tonicity-adjusting agent. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefuroxime (C16H16N4O8S).
Packaging and storage—
Preserve in Containers for Injections as described under Injections 
1
. Maintain in the frozen state.
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.
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.
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Identification—
The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for cefuroxime, 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 0.10 USP Endotoxin Unit per mg of cefuroxime.
85—
It contains not more than 0.10 USP Endotoxin Unit per mg of cefuroxime.
Sterility 71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
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 5.0 and 7.5.
791:
between 5.0 and 7.5.
Particulate matter 788:
meets the requirements for small-volume injections.
788:
meets the requirements for small-volume injections.
Other requirements—
It meets the requirements for Uniformity of Dosage Units 905.
905.
Assay—
pH 3.4 Acetate buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—
Prepare as directed in the Assay under Cefuroxime Sodium.
Assay preparation—
Allow a container of Injection to thaw, and mix the solution. Transfer an accurately measured volume of the Injection, equivalent to about 50 mg of cefuroxime, to a 50-mL volumetric flask, dilute with water to volume, and mix. Immediately transfer 5.0 mL of this solution to a second 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix.
Procedure—
Proceed as directed for Procedure in the Assay under Cefuroxime Sodium. Calculate the quantity, in mg, of cefuroxime (C16H16N4O8S) in each mL of the Injection taken by the formula:
1000(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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 2581