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 90.0 percent and not more than 110.0 percent 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 191 and for Chloride 191.
Sterility 71: meets the requirements.
pH 791: between 4.5 and 7.0.
Assay— Pipet a volume of Inhalation Solution, equivalent to about 90 mg of sodium chloride, into a conical flask, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 0.5 mL of eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl.
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Topic/Question Contact Expert Committee
Monograph Kahkashan Zaidi, Ph.D.
Senior Scientist
(AER05) Aerosols05
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3571