Sodium Chloride Inhalation Solution
»Sodium Chloride Inhalation Solution is a sterile solution of Sodium Chloride in water purified by distillation or by reverse osmosis and rendered sterile.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of NaCl.It contains no antimicrobial agents or other added substances.
Packaging and storage— Preserve in single-dose containers.
Identification— It responds to the test for Sodium á191ñand for Chloride á191ñ.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.5and 7.0.
Assay— Pipet a volume of Inhalation Solution,equivalent to about 90mg of sodium chloride,into a conical flask,and add 10mLof glacial acetic acid,75mLof methanol,and 0.5mLof eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of NaCl.
Auxiliary Information— Staff Liaison:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate
Expert Committee:(AER)Aerosols
USP28–NF23Page 1781
Phone Number:1-301-816-8269
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