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 95.0percent and not more than 105.0percent 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 Identificationtests under Ribavirin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.0and 6.5,in the solution constituted as directed in the labeling,to each 50mLof which has been added 0.2mLof 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 10µLof the Test solutioninto 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 solutionby the formula:
100ri/rt,
in which riis the response of the individual peak,and rtis 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 metalsunder Ribavirin.
Assay—
Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder 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 100mg of ribavirin,to a 200-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Assay preparation— Transfer 5.0mLof the Test solutionto a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Ribavirin.Calculate the quantity,in mg,of ribavirin (C8H12N4O5)in each mLof the constituted Inhalation Solution taken by the formula:
4000(C/V)(rU/rS),
in which Vis the volume,in mL,of constituted Inhalation Solution taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1722
Phone Number:1-301-816-8335
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