Cromolyn Sodium Ophthalmic Solution
» Cromolyn Sodium Ophthalmic Solution is a sterile, 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 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 for Identification test B under Cromolyn Sodium.
Sterility 71: meets the requirements.
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, “Ophthalmic Solution” being read in place of “Inhalation Solution.”
pH 7.4 Sodium phosphate buffer— Prepare as directed in the Assay under Cromolyn Sodium.
Assay preparation— Transfer 4 mL of Ophthalmic 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 Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2032
Pharmacopeial Forum: Volume No. 28(4) Page 1094