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.
Chromatographic purity—
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 / rt,
in 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.
Assay—
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 (C
8H
12N
4O
5) 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.
