Sodium Chloride Ophthalmic Ointment
» Sodium Chloride Ophthalmic Ointment is Sodium Chloride in a suitable ophthalmic ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of NaCl. It is sterile.
Packaging and storage Preserve in collapsible ophthalmic ointment tubes.
Identification Transfer a quantity of Ophthalmic Ointment, equivalent to about 200 mg of sodium chloride, to a separator containing about 25 mL of ether, and extract with 5 mL of water: the aqueous extract so obtained responds to the tests for Sodium 191, and for Chloride 191.
Sterility 71: meets the requirements.
Minimum fill 755: meets the requirements.
Metal particles 751: meets the requirements.
Assay Transfer an accurately weighed quantity of Ophthalmic Ointment, equivalent to about 100 mg of sodium chloride, to a separator containing about 50 mL of ether, and extract with four 20-mL portions of water. Combine the aqueous extracts in a conical flask, evaporate to a volume of about 10 mL, 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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USP32NF27 Page 3571Pharmacopeial Forum: Volume No. 27(6) Page 3329