Guaifenesin Syrup, chemical structure, molecular formula, Reference Standards

Guaifenesin Syrup

(Current title—not to change until June 1,2005)

Monograph title change—to become official June 1,2005

See Guafenesin Oral Solution

»Guaifenesin Syrup 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.

USP Reference standards á11ñ— USP Guaifenesin RS.

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 SYRUP PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

USP28

Add the following:

Deliverable volume á698ñ—

FOR SYRUP 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 Syrup,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 Syrup taken by the formula:

5C/V(rU/rS),

in which Vis the volume,in mL,of Syrup taken;and the other terms are as defined therein.

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