A: Infrared Absorption á197Kñ.

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

C: 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.

Test solution: 25mg per mL.

Phosphate buffer— Mix 1.0mLof phosphoric acid with 2Lof water,and adjust with potassium hydroxide to a pHof 3.0.

Mobile phase— Prepare a mixture of Phosphate bufferand acetonitrile (3:2).Sonicate for 15minutes,and pass through a filter having a 0.5-µm or finer porosity.Make adjustments if necessary (see System SuitabilityunderChromatography á621ñ).

Standard preparation— 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.

Assay preparation— Transfer about 100mg of Glucosamine Hydrochloride,accurately weighed,to a 100-mLvolumetric flask.Dissolve in 30mLof water,shake by mechanical means,dilute with water to volume,and mix.

Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 195-nm detector and a 4.6-mm ×25-cm column that contains packing L7.The flow rate is about 0.6mLper minute.Chromatograph the Standard preparation,and record the responses as directed for Procedure:the tailing factor for the glucosamine peak is not more than 2.0;and the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the glucosamine peaks.Calculate the percentage of C6H13NO5·HCl in the portion of Glucosamine Hydrochloride taken by the formula: in which Cis the concentration,in mg per mL,of USP Glucosamine Hydrochloride RSin the Standard preparation;Wis the weight,in mg,of Glucosamine Hydrochloride used to prepare the Assay preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.