Sodium Chloride Ophthalmic Ointment
»Sodium Chloride Ophthalmic Ointment is Sodium Chloride in a suitable ophthalmic ointment base.It contains not less than 90.0percent and not more than 110.0percent 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 200mg of sodium chloride,to a separator containing about 25mLof ether,and extract with 5mLof water:the aqueous extract so obtained responds to the tests forSodium á191ñ,and forChloride á191ñ.
Sterility á71ñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Metal particles á751ñ: meets the requirements.
Assay— Transfer an accurately weighed quantity of Ophthalmic Ointment,equivalent to about 100mg of sodium chloride,to a separator containing about 50mLof ether,and extract with four 20-mLportions of water.Combine the aqueous extracts in a conical flask,evaporate to a volume of about 10mL,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
Pharmacopeial Forum:Volume No.27(6)Page 3329
Phone Number:1-301-816-8379