Rifampin for Injection
» Rifampin for Injection contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of rifampin (C43H58N4O12).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
A: It responds to Identification test A under Rifampin Capsules, the test solution being prepared by dissolving the contents of a container in chloroform to obtain a solution containing about 10 mg of rifampin per mL.
B: The retention time of the rifampin 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 85 Dissolve Rifampin for Injection in endotoxin-free water to obtain a stock solution containing 10 mg of rifampin per mL. Dilute the stock solution quantitatively, and stepwise if necessary, with endotoxin-free water to obtain a solution containing 0.12 mg of rifampin per mL: it contains not more than 0.5 USP Endotoxin Unit per mg of rifampin.
Sterility 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 7.8 and 8.8, in a solution containing 60 mg of rifampin per mL.
Water, Method I 921: not more than 1.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Phosphate buffer, Mobile phase, Solvent mixture, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Rifampin.
Assay preparation 1 (where it is represented as being in a single-dose container)Constitute a container of Rifampin for Injection in a volume of water, accurately measured, corresponding to the volume of diluent specified in the labeling. [noteUse this solution within 2 hours.] Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and transfer to a suitable volumetric flask of such capacity that when diluted with acetonitrile to volume, a solution is obtained containing about 6 mg of rifampin (C43H58N4O12) per mL. [noteUse this stock solution within 5 hours.] Dilute an accurately measured volume of this stock solution quantitatively and stepwise with Solvent mixture to obtain a solution having a concentration of about 0.02 mg of rifampin per mL. [notePrepare this final dilution immediately prior to injection into the chromatograph.]
Assay preparation 2 (where the label states the quantity of rifampin in a given volume of constituted solution)Constitute a container of Rifampin for Injection in a volume of water, accurately measured, equivalent to the volume of diluent specified in the labeling. [noteUse this solution within 2 hours.] Dilute an accurately measured volume of the constituted solution quantitatively and stepwise with acetonitrile to obtain a solution having a concentration of about 0.2 mg of rifampin (C43H58N4O12) per mL. [noteUse this stock solution within 5 hours.] Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with Solvent mixture to volume, and mix. [notePrepare this final dilution immediately prior to the injection into the chromatogram.]
Procedure Proceed as directed for Procedure in the Assay under Rifampin. Calculate the quantity, in mg, of rifampin (C43H58N4O12) withdrawn from the container of constituted Rifampin for Injection, or in the volume of constituted Rifampin for Injection taken by the formula:
(L / D)(C)(rU / rS)in which L is the labeled quantity, in mg, of rifampin in the container, or in the volume of constituted solution taken, D is the concentration, in mg per mL, of rifampin in Assay preparation 1 or in Assay preparation 2, on the basis of the labeled quantity in the container, or in the volume of constituted solution taken, and the extent of dilution, C is the concentration, in mg per mL, calculated on the dried basis, of USP Rifampin RS in the Standard preparation, and rU and rS are the rifampin peak responses obtained from Assay preparation 1, or Assay preparation 2, and the Standard preparation, respectively.
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USP32NF27 Page 3503
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.