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Naphazoline hydrochloride (CAS No 550-99-2), Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%, a sterile solution, is an ocular vasoconstrictor and imidazoline derivative sympathomimetic amine. It occurs as a white, odorless, crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is represented by the following structural formula:
Mol. Wt 246.74
Loss on drying ≤2.0%
Heavy metals ≤10 ppm
Sulphated ash ≤0.5%, determined on 1.0 g.
Related substances Unspecified impurities: for each impurity≤0.10%
Total Impurity ≤0.5%
Assay 99.0%~101.0% (anhydrous substance).
Total plate count ≤1000cfu/g
Yeast and Moulds ≤100cfu/g
E. Coli. Absent
Used to relieve redness, puffiness, and itchy/watering eyes due to colds, allergies, or eye irritations (smog, swimming, or wearing contact lenses). It is known as a sympathomimetic (alpha receptor agonist) that works in the eye to decrease congestion.
Preserved in well-closed, light-resistant and airtight containers.