Identification—
Transfer to a beaker a volume of Solution, equivalent to about 1 g of sulfacetamide sodium, and dilute with water to 25 mL. Adjust with 6 N acetic acid to a pH of between 4 and 5, and filter. Wash the precipitate with water, and dry at 105
for 2 hours: the sulfacetamide so obtained melts between 180
and 184
, and responds to
Identification tests
B and
E under
Sulfacetamide Sodium.
Assay—
Assay preparation—
Transfer an accurately measured volume of Ophthalmic Solution, freshly mixed and free from air bubbles, equivalent to about 100 mg of sulfacetamide, to a 100-mL volumetric flask, dilute with a mixture of water and methanol (4:1) to volume, and mix. Dilute 3.0 mL of this solution with the same solvent mixture to 100.0 mL, and mix.
Procedure—
Proceed as directed in the
Assay under
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.
Sulfacetamide Sodium Ophthalmic Solution is a sterile solution containing not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C8H9N2NaO3S·H2O. It may contain suitable buffers, stabilizers, and antimicrobial agents.
71
:
meets the requirements.