Atropine Sulfate Ophthalmic Ointment
» Atropine Sulfate Ophthalmic Ointment is Atropine Sulfate in a suitable ophthalmic ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of (C17H23NO3)2·H2 SO4·H2O. It is sterile.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
A: Transfer a portion of Ophthalmic Ointment, equivalent to about 50 mg of atropine sulfate, to a suitable separator, and dissolve in 25 mL of ether. Add 25 mL of 0.01 N hydrochloric acid, shake vigorously, allow the layers to separate, and discard the organic phase. Heat the aqueous phase gently on a steam bath while passing nitrogen through the solution, to expel any residual ether. Proceed as directed under Identification—Organic Nitrogenous Bases 181, beginning with “In a second separator dissolve 50 mg.”
B: Transfer about 5 g of Ophthalmic Ointment to a separator, dissolve in 50 mL of ether, and extract with 20 mL of water: the extracted solution so obtained responds to the tests for Sulfate 191.
Sterility 71: It meets the requirements.
Metal particles 751: It meets the requirements.
Assay— Proceed with Ophthalmic Ointment as directed in the Assay under Atropine Sulfate Ophthalmic Solution, but in preparing the Assay preparation, weigh accurately a portion of Ophthalmic Ointment, equivalent to about 10 mg of atropine sulfate, transfer to a separator containing 50 mL of ether, shake to dissolve, extract with three 25-mL portions of 0.1 M sulfuric acid, collect the acid extracts in a 100-mL volumetric flask, dilute with 0.1 M sulfuric acid to volume, and mix. Proceed as directed for the Assay preparation in the Assay under Atropine Sulfate Ophthalmic Solution, beginning with “Pipet 10 mL of this solution into a separator.” Calculate the quantity, in mg, of atropine sulfate [(C17H23NO3)2·H2SO4·H2O] in the portion of Ophthalmic Ointment taken by the formula given therein.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1605
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.