Identification—
Place in a 125-mL separator a volume of Ophthalmic Solution, equivalent to about 50 mg of cyclopentolate hydrochloride, and place in a second separator about 50 mg of
USP Cyclopentolate Hydrochloride RS dissolved in 5 mL of water. Treat each solution as follows. Add 1 g of potassium carbonate, and extract with two 10-mL portions of ether. Pass the ether extracts through ether-washed filter paper, collect the filtrate in a small beaker, and evaporate to dryness: the residue so obtained responds to
Identification test
A under
Cyclopentolate Hydrochloride.
Assay—
Assay preparation—
Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 10 mg of cyclopentolate hydrochloride, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure—
Proceed as directed in the
Assay under
Cyclopentolate Hydrochloride. Calculate the quantity, in mg, of cyclopentolate hydrochloride (C
17H
25NO
3·HCl) in each mL of the Ophthalmic Solution taken by the formula:
100(C / V)(rU / rS),
in which
V is the volume, in mL, of Ophthalmic Solution taken, and the other terms are as defined therein.
71
:
meets the requirements.