Cromolyn Sodium Nasal Solution
» Cromolyn Sodium Nasal Solution is an aqueous solution of Cromolyn Sodium. It contains not less than 90.0 percent and not more than 110.0 percent 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 for Identification test B under Cromolyn Sodium.
pH 791: between 4.0 and 7.0.
Related compounds— It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, “Nasal Solution” being read in place of “Inhalation Solution.”
Assay—
pH 7.4 Sodium phosphate buffer— Prepare as directed in the Assay under Cromolyn Sodium.
Assay preparation— Transfer 4 mL of Nasal Solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer an aliquot of this solution, equivalent to 8 mg of cromolyn sodium, to a 250-mL volumetric flask. Add 2.5 mL of pH 7.4 Sodium phosphate buffer, dilute with water to volume, and mix.
Standard preparation— Prepare as directed in the Assay under Cromolyn Sodium.
Procedure— Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Kahkashan Zaidi, Ph.D.
Senior Scientist
1-301-816-8269		 (AER05) Aerosols05
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2031
Pharmacopeial Forum: Volume No. 28(4) Page 1093