Cyclopentolate Hydrochloride Ophthalmic Solution
» 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·HCl.
Packaging and storage— Preserve in tight containers, and store at controlled room temperature.
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 71: meets the requirements.
pH 791: between 3.0 and 5.5.
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·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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
Scientist
1-301-816-8320
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2040
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.