Guaifenesin Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Guaifenesin Syrup)
»Guaifenesin Oral Solution contains not less than 90.0percent and not more than 110.0percent 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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Add the following:
Uniformity of dosage units á905ñ—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.USP28
Add the following:
Deliverable volume á698ñ—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.USP28
pHá791ñ: between 2.3and 3.0.
Alcohol content,Method Iá611ñ(if present): between 90.0%and 115.0%of the labeled amount of C2H5OH.
Assay—
Mobile phase,Benzoic acid solution,Resolution solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Guaifenesin Tablets.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 200mg of guaifenesin,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 2.0mLof this solution to a 100-mLvolumetric flask,add 45mLof methanol,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Guaifenesin Tablets.Calculate the quantity,in mg,of guaifenesin (C10H14O4)in each mLof the Oral Solution taken by the formula:
5C/V(rU/rS),
in which Vis the volume,in mL,of Oral Solution taken;and the other terms are as defined therein.
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 924
Pharmacopeial Forum:Volume No.30(1)Page 107
Phone Number:1-301-816-8139
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