Chloramphenicol Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Chloramphenicol Injection is a sterile solution of Chloramphenicol in one or more suitable solvents. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C11H12Cl2N2O5.. It may contain suitable buffers.
Packaging and storage—Preserve in single-dose or in multiple-dose containers.
Labeling—Label it to indicate that it is for veterinary use only.
USP Reference standards 〈11
USP Chloramphenicol RS
Identification—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 Test 〈85〉 —It contains not more than 0.2 USP Endotoxin Unit per mg of chloramphenicol.
Sterility Tests 〈71〉 —It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, 1 mL from each container being transferred directly to the membrane filter.
pH 〈791〉: between 5.0 and 8.0, in a solution diluted with water (1:1).
Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.
Assay
Mobile phase, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Chloramphenicol. Assay preparation—Transfer an accurately measured volume of Chloramphenicol Injection, equivalent to about 200 mg of chloramphenicol, to a 100-mL volumetric flask, add Mobile phase to volume, and mix. Transfer 4.0 mL of the resulting solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Filter this solution through a 0.5-µm or finer porosity filter.
Procedure—Proceed as directed for Procedure in the Assay under Chloramphenicol. Calculate the quantity, in mg, of C11H12Cl2N2O5. in each mL of the Injection taken by the formula:
2.5(C/V)(rU/rS)
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
