SPL Set ID: 1e87a81a-7084-4436-918b-a50451534307

Pilocarpine hydrochloride ophthalmic solution, USP is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established Name: pilocarpine hydrochloride, USP Chemical Name: 2(3 H )-furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)-methyl]-monohydrochloride, (3S- cis ). Molecular Formula: C 11 H 16 N 2 O 2 • HCl Molecular Weight: 244.72 Pilocarpine hydrochloride, USP is a white or almost white, crystalline powder or colorless crystals hygroscopic. It is very soluble in water, freely soluble in alcohol, slightly soluble in chloroform and insoluble in ether. Each mL of pilocarpine hydrochloride ophthalmic solution, USP contains: Active: pilocarpine hydrochloride, USP 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: benzalkonium chloride 0.01%. Inactives: 0.5% hypromellose 2910; boric acid; sodium citrate; sodium chloride (present in 1% product only); hydrochloric acid and/or sodium hydroxide (to adjust pH); water for injection. Pilocarpine hydrochloride ophthalmic solution, USP has a pH of 3.5 to 5.5 and an osmolality of 270 to 350 mOsm/kg (1% product), 290 to 350 mOsm/kg (2% product) and 500 to 600 mOsm/kg (4% product). ab