Cromolyn Sodium Ophthalmic Solution
»Cromolyn Sodium Ophthalmic Solution is a sterile,aqueous solution of Cromolyn Sodium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C23H14Na2O11.It may contain suitable antimicrobial and stabilizing agents.
Packaging and storage— Preserve in tight,light-resistant,single-dose or multiple-dose containers.Ophthalmic Solution that is packaged in multiple-dose containers contains a suitable antimicrobial agent.
Identification— It meets the requirements forIdentification testBunderCromolyn Sodium.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.0and 7.0.
Related compounds— It meets the requirements of the test forRelated compoundsunderCromolyn Sodium Inhalation Solution,“Ophthalmic Solution”being read in place of “Inhalation Solution.”
Assay—
pH7.4Sodium phosphate buffer— Prepare as directed in theAssayunderCromolyn Sodium.
Assay preparation— Transfer 4mLof Ophthalmic Solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer an aliquot of this solution,equivalent to 8mg of cromolyn sodium,to a 250-mLvolumetric flask.Add 2.5mLofpH7.4Sodium phosphate buffer,dilute with water to volume,and mix.
Standard preparation— Prepare as directed in theAssayunderCromolyn Sodium.
Procedure— Proceed as directed forProcedure in theAssay underCromolyn Sodium Inhalation Solution.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 551
Pharmacopeial Forum:Volume No.28(4)Page 1094
Phone Number:1-301-816-8379
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