Cromolyn Sodium Nasal Solution
»Cromolyn Sodium Nasal Solution is an 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 stabilizers.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— It meets the requirements forIdentification testBunderCromolyn Sodium.
pHá791ñ: between 4.0and 7.0.
Related compounds— It meets the requirements of the test forRelated compoundsunderCromolyn Sodium Inhalation Solution,“Nasal Solution”being read in place of “Inhalation Solution.”
Assay—
pH7.4Sodium phosphate buffer— Prepare as directed in theAssayunderCromolyn Sodium.
Assay preparation— Transfer 4mLof Nasal 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:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate
Expert Committee:(AER)Aerosols
USP28–NF23Page 550
Pharmacopeial Forum:Volume No.28(4)Page 1093
Phone Number:1-301-816-8269