U.S. PHARMACOPEIA

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Guaifenesin Oral Solution
Former title:Guaifenesin Syrup
» Guaifenesin Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of guaifenesin (C10H14O4).
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the guaifenesin peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pH 791: between 2.3 and 3.0.
Alcohol content, Method I 611 (if present): between 90.0% and 115.0% of the labeled amount of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Benzoic acid solution, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Guaifenesin Tablets.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 200 mg of guaifenesin, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 2.0 mL of this solution to a 100-mL volumetric flask, add 45 mL of methanol, dilute with water to volume, and mix.
Procedure— Proceed as directed in the Assay under Guaifenesin Tablets. Calculate the quantity, in mg, of guaifenesin (C10H14O4) in each mL of the Oral Solution taken by the formula:
5C/V(rU / rS),
in which V is the volume, in mL, of Oral Solution taken; and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1030
Pharmacopeial Forum : Volume No. 30(1) Page 107
Phone Number : 1-301-816-8139