A: Infrared Absorption 197K.

B: It meets the requirements of the tests for Chloride 191.

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

Test solution: 25 mg per mL.

(Official January 1, 2007)

Phosphate buffer— Mix 1.0 mL of phosphoric acid with 2 L of water, and adjust with potassium hydroxide to a pH of 3.0.

Mobile phase— Prepare a mixture of Phosphate buffer and acetonitrile (3:2). Sonicate for 15 minutes, and pass through a filter having a 0.5-µm or finer porosity. Make adjustments if necessary (see System Suitability under Chromatography 621).

Standard preparation— Dissolve an accurately weighed quantity of USP Glucosamine Hydrochloride RS in water to obtain a solution having a known concentration of about 1.0 mg per mL.

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

Chromatographic system (see Chromatography 621)— 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 0.6 mL per 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 10 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg per mL, of USP Glucosamine Hydrochloride RS in the Standard preparation; W is the weight, in mg, of Glucosamine Hydrochloride used to prepare the Assay preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.