Chloramphenicol Oral Solution
» Chloramphenicol Oral Solution is a solution of Chloramphenicol in a suitable solvent. It contains one or more suitable buffers and preservatives. It has a potency of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C11H12Cl2N2O5.
Packaging and storage
Preserve in tight containers.
Labeling
Label it to indicate that it is for veterinary use only and that it is not to be used in animals raised for food production.
Identification
Transfer a volume of Oral Solution, equivalent to about 250 mg of chloramphenicol, to a 250-mL volumetric flask. Add 50 mL of methanol, shake for 1 minute, dilute with water to volume, and mix. Pipet 5 mL of this solution into a 250-mL volumetric flask, dilute with water to volume, and mix. The ultraviolet absorption spectrum of the solution so obtained exhibits maxima and minima only at the same wavelengths as that of a similar solution of USP Chloramphenicol RS, concomitantly measured.
pH 791:
between 5.0 and 8.5, when diluted with an equal volume of water.
Assay
Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately measured volume of Oral Solution diluted quantitatively and stepwise with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1887
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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