Ribavirin for Inhalation Solution
» Ribavirin for Inhalation Solution is a sterile, freeze-dried form of ribavirin. When constituted as directed in the labeling, the inhalation solution so obtained contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of ribavirin (C8H12N4O5).
Packaging and storage Preserve in tight containers, in a dry place at controlled room temperature.
Labeling The labeling indicates that Ribavirin for Inhalation Solution must be constituted with a measured volume of Sterile Water for Injection or with Sterile Water for Inhalation containing no preservatives, and that the constituted solution is to be administered only by a small-particle aerosol generator.
Identification It responds to the Identification tests under Ribavirin.
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 4.0 and 6.5, in the solution constituted as directed in the labeling, to each 50 mL of which has been added 0.2 mL of a saturated potassium chloride solution.
Mobile phase, Standard preparation, Test solution, and Chromatographic system Prepare as directed in the Assay.
Procedure Inject about 10 µL of the Test solution into the chromatograph, record the chromatogram, and measure the responses of all the peaks, except that of the solvent peak. Calculate the percentage of each peak, other than that of the ribavirin peak, in the chromatogram of the Test solution by the formula:
100ri / rtin which ri is the response of the individual peak, and rt is the sum of the responses of all the peaks in the chromatogram: not more than 0.25% of any individual peak is found, and the sum of all such peaks does not exceed 1.0%.
Other requirements It meets the requirements for Specific rotation, Loss on drying, Residue on ignition, and Heavy metals under Ribavirin.
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Ribavirin.
Test solution Constitute Ribavirin for Inhalation Solution as directed in the labeling, using an accurately measured volume of diluent. Transfer an accurately measured volume of the constituted inhalation solution, equivalent to about 100 mg of ribavirin, to a 200-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Assay preparation Transfer 5.0 mL of the Test solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Ribavirin. Calculate the quantity, in mg, of ribavirin (C8H12N4O5) in each mL of the constituted Inhalation Solution taken by the formula:
4000(C / V)(rU / rS)in which V is the volume, in mL, of constituted Inhalation Solution taken, and the other terms are as defined therein.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3497
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.