Sulfacetamide Sodium Ophthalmic Solution
»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.
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 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.
Sterility 71: meets the requirements.
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Proceed as directed in the Assay under Sulfacetamide Sodium Ophthalmic Ointment.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3614
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.