Sodium Chloride Ophthalmic Solution
» Sodium Chloride Ophthalmic Solution is a sterile solution of Sodium Chloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sodium chloride. It may contain suitable antimicrobial and stabilizing agents. It contains a buffer.
Packaging and storage— Preserve in tight containers.
Identification— Heat a portion of Ophthalmic Solution to boiling, and filter while hot. After cooling, the filtrate responds to the tests for Sodium 191 and for Chloride 191.
Sterility 71: meets the requirements.
pH 791: between 6.0 and 8.0.
Assay— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 90 mg of sodium chloride, to 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 Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3572