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.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1781

Phone Number:1-301-816-8379