Cyclopentolate Hydrochloride Ophthalmic Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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Cyclopentolate Hydrochloride Ophthalmic Solution is a sterile, aqueous solution of Cyclopentolate Hydrochloride. It may contain suitable buffers and other additives. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₁₇H₂₅NO₃ . HCI.

1 Packaging and storage

Preserve in tight containers, and store at controlled room temperature.

1.1 USP REFERENCE STANDARDS (11)

USP Cyclopentolate Hydrochloride RS

2 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.

STERILITY TESTS (71): meets the requirements.

PH (791): between 3.0 and 5.5.

3 Assay

Buffer solution, Mobile phase, Standard preparation, and Chromatographic system-Proceed as directed in the Assay under Cyclopentolate Hydrochloride.

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 (C₁₇H₂₅NO₃ . HCI) in each mL of the Ophthalmic Solution taken by the formula:

100(C/V)(r_u/r_s)

in which V is the volume, in mL, of Ophthalmic Solution taken, and the other terms are as defined therein.