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Sodium Chloride Ophthalmic Solution
»Sodium Chloride Ophthalmic Solution is a sterile solution of Sodium Chloride.It contains not less than 90.0percent and not more than 110.0percent 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 á191ñand for Chloride á191ñ.
Sterility á71ñ:
meets the requirements.
pHá791ñ:
between 6.0and 8.0.
Assay—
Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 90mg of sodium chloride,to 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:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1781
Phone Number:1-301-816-8379
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