A: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

B: It meets the requirements of the tests for Chloride á191ñ.

C: It meets the requirements of the tests for Sulfate á191ñ(only for Tablets labeled as containing glucosamine sodium sulfate or glucosamine potassium sulfate).

Medium: water;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Phosphate buffer,Mobile phase,and Chromatographic system— Proceed as directed in the Assayunder Glucosamine Hydrochloride.

Standard solution— Dissolve an accurately weighed quantity of USP Glucosamine Hydrochloride RSin water to obtain a solution having a known concentration of about 1.0mg per mL.Dilute with a suitable quantity of water,if necessary.

Test solution— Use the solution under test.

Procedure— Separately inject equal volumes (about 10µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the areas for the glucosamine peaks.Calculate the amount,in mg,of glucosamine (C6H13NO5)dissolved by the formula: in which 179.17and 215.63are the molecular weights of glucosamine and glucosamine hydrochloride,respectively;Cis the concentration,in mg per mL,of USP Glucosamine Hydrochloride RSin the Standard solution;and rUand rSare the peak responses obtained from the Test solutionand Standard solution,respectively.

Tolerances— Not less than 75%of the labeled amount of C6H13NO5is dissolved in 45minutes.

Phosphate buffer,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Glucosamine Hydrochloride.

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the finely powdered material,equivalent to about 80mg of glucosamine,to a 100-mLvolumetric flask,add 60mLof water,and sonicate for 10minutes.Shake by mechanical means for 15minutes.Dilute with water to volume,and mix.Pass a portion of this solution through a membrane filter having a 0.45-µm or finer porosity.

Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of glucosamine (C6H13NO5)in the portion of Tablets taken by the formula: in which 179.17and 215.63are the molecular weights of glucosamine and glucosamine hydrochloride,respectively;Cis the concentration,in mg per mL,of USP Glucosamine Hydrochloride RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.