Packaging and storage—
Preserve in single-dose or in multiple-dose containers.
Labeling—
Label it to indicate that it is for veterinary use only.
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.
Sterility 
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 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 C
11H
12Cl
2N
2O
5 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.
