SPL Set ID: 46e98d0b-3a04-7feb-e063-6394a90ac75e

Atropine sulfate ophthalmic solution, 1% contains atropine an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •H 2 O Molecular Weight: 694.84 g/mol Atropine sulfate appears as white or almost white, crystalline powder, or colorless crystals. It is very soluble in water and freely soluble in ethanol (96%). Atropine sulfate ophthalmic solution, USP 1% is a clear, colorless, slightly viscous solution. Each mL of Atropine Sulfate Ophthalmic Solution, USP 1% contains: Active : atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), edetate disodium dihydrate, hypromellose (methocel E4M premium), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. Chemical Structure