Cromolyn Sodium Inhalation Solution
» Cromolyn Sodium Inhalation 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.
Packaging and storage— Preserve in single-unit double-ended glass ampuls or in low-density polyethylene ampuls.
Labeling— The label indicates that the Inhalation Solution is not to be used if it contains a precipitate.
Identification— The UV absorption spectrum of the Assay preparation prepared as directed in the Assay exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Cromolyn Sodium RS, concomitantly measured.
Sterility 71: meets the requirements.
Uniformity of dosage units 905: meets the requirements.
pH 791: between 4.0 and 7.0.
Related compounds— Apply 10-µL portions of Inhalation Solution and Standard solutions of USP Cromolyn Sodium RS in a mixture of water, stabilizer-free tetrahydrofuran, and acetone (6:4:1) containing 10 mg per mL (Standard solution A) and 0.1 mg per mL (Standard solution B) to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and glacial acetic acid (9:9:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by viewing under short-wavelength UV light: the RF value of the principal spot obtained from the Inhalation Solution corresponds to that obtained from Standard solution A. Any spot in the chromatogram obtained from the Inhalation Solution moving ahead of the principal spot is not more intense than the spot in the chromatogram obtained from Standard solution B (1.0%).
Assay—
pH 7.4 Sodium phosphate buffer and Standard preparation—Prepare as directed in the Assay under Cromolyn Sodium.
Assay preparation— Dilute with water an accurately measured volume of Inhalation Solution, equivalent to about 25 mg of cromolyn sodium, to obtain a solution having a concentration of about 250 µg per mL. Pipet 10 mL of this solution into a 100-mL volumetric flask, add 1 mL of pH 7.4 Sodium phosphate buffer, dilute with water to volume, and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparation and the Assay preparation in 1-cm cells at the wavelength of maximum absorbance at about 326 nm, with a suitable spectrophotometer, using a 1 in 100 aqueous solution of pH 7.4 Sodium phosphate buffer as the blank. Calculate the quantity, in mg, of C23H14Na2O11 in each mL of the Inhalation Solution taken by the formula:
(C/V)(AU / AS)
in which C is the concentration, in µg per mL, of USP Cromolyn Sodium RS in the Standard preparation; V is the volume, in mL, of Inhalation Solution taken; and AU and AS are the absorbances of the solutions obtained from the Assay preparation and the Standard preparation, respectively.
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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
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2031