Sulfacetamide Sodium Ophthalmic Solution
»Sulfacetamide Sodium Ophthalmic Solution is a sterile solution containing not less than 90.0percent and not more than 110.0percent of the labeled amount of C8H9N2NaO3S·H2O.It may contain suitable buffers,stabilizers,and antimicrobial agents.
Packaging and storage— Preserve in tight,light-resistant containers,in a cool place.
Identification— Transfer to a beaker a volume of Solution,equivalent to about 1g of sulfacetamide sodium,and dilute with water to 25mL.Adjust with 6Nacetic acid to a pHof between 4and 5,and filter.Wash the precipitate with water,and dry at 105for 2hours:the sulfacetamide so obtained melts between 180and 184,and responds to Identificationtests Band Eunder Sulfacetamide Sodium.
Sterility á71ñ: meets the requirements.
Assay—
Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Proceed as directed in the Assayunder Sulfacetamide Sodium Ophthalmic Ointment.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,freshly mixed and free from air bubbles,equivalent to about 100mg of sulfacetamide,to a 100-mLvolumetric flask,dilute with a mixture of water and methanol (4:1)to volume,and mix.Dilute 3.0mLof this solution with the same solvent mixture to 100.0mL,and mix.
Procedure— Proceed as directed in the Assayunder Sulfacetamide Sodium Ophthalmic Ointment.Calculate the quantity,in mg,of sulfacetamide sodium in the portion of Ophthalmic Solution taken by the formula:
3.33(254.24/236.23)C(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1817
Phone Number:1-301-816-8394