Chloramphenicol Sodium Succinate for Injection
» Chloramphenicol Sodium Succinate for Injection contains an amount of Chloramphenicol Sodium Succinate equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of chloramphenicol (C11H12Cl2N2O5).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Chloramphenicol RS Click to View Structure
USP Endotoxin RS
Bacterial endotoxins 85 It contains not more than 0.2 USP Endotoxin Unit per mg of chloramphenicol.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter 788: meets the requirements for small-volume injections.
Limit of free chloramphenicol—
Mobile phase, Standard solution, and Chromatographic system Proceed as directed in the test for Limit of free chloramphenicol under Chloramphenicol Sodium Succinate.
Test solution— Dissolve the contents of 1 container in a volume of Mobile phase to obtain a solution containing the equivalent of about 100 mg of chloramphenicol per mL. Dilute this solution quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution containing the equivalent of about 0.5 mg of chloramphenicol per mL. Pass a portion of this solution through a filter having a 0.5-µm or finer porosity, and use the filtrate.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the areas for the free chloramphenicol peaks. Calculate the percentage of free chloramphenicol (C11H12Cl2N2O5) in the specimen taken by the formula:
0.1(C / D)(rU / rS)
in which C is the concentration, in µg per mL, of USP Chloramphenicol RS in the Standard solution; D is the concentration, in mg per mL, of chloramphenicol equivalent in the Test solution, based on the labeled quantity in the container and the extent of dilution; and rU and rS are the chloramphenicol peak areas obtained from the Test solution and the Standard solution, respectively. Not more than 2.0% is found.
Other requirements— It meets the requirements of the tests for Identification, Specific rotation, pH, and Water under Chloramphenicol Sodium Succinate.
Assay—
Standard preparation— Proceed as directed in the Assay under Chloramphenicol Sodium Succinate.
Assay preparation— Constitute 1 container of Chloramphenicol Sodium Succinate for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution having a concentration of about 20 µg of chloramphenicol per mL.
Procedure— Proceed as directed in the Assay under Chloramphenicol Sodium Succinate. Calculate the quantity, in mg, of chloramphenicol (C11H12Cl2N2O5), in each mL of the constituted Chloramphenicol Sodium Succinate for Injection taken by the formula:
(L / D)(CP / 1000)(AU / AS)
in which L is the labeled quantity, in mg, of chloramphenicol in each mL of constituted solution; D is the concentration, in µg per mL, of chloramphenicol in the Assay preparation, on the basis of the labeled quantity of chloramphenicol in each mL of constituted solution and the extent of dilution; C is the concentration, in µg per mL, of USP Chloramphenicol RS in the Standard preparation; P is the potency, in µg per mg, of USP Chloramphenicol RS; and AU and AS are the absorbances of the Assay preparation and the Standard preparation, respectively.
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