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 90.0percent and not more than 110.0percent 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-mLseparator a volume of Ophthalmic Solution,equivalent to about 50mg of cyclopentolate hydrochloride,and place in a second separator about 50mg of USP Cyclopentolate Hydrochloride RSdissolved in 5mLof water.Treat each solution as follows.Add 1g of potassium carbonate,and extract with two 10-mLportions 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 Identificationtest Aunder Cyclopentolate Hydrochloride.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 3.0and 5.5.
Assay—
Buffer solution,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Cyclopentolate Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 10mg of cyclopentolate hydrochloride,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Cyclopentolate Hydrochloride.Calculate the quantity,in mg,of cyclopentolate hydrochloride (C17H25NO3·HCl)in each mLof the Ophthalmic Solution taken by the formula:
100(C/V)(rU/rS),
in which Vis the volume,in mL,of Ophthalmic Solution taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 557
Phone Number:1-301-816-8389