USP-NF Glucosamine Hydrochloride

付费版美国药典文件

2011-1-10USP-NF

Glucosamine Hydrochloride

C6H13NO5·HCl215.63

D-Glucose, 2-amino-2-deoxy-, hydrochloride.

2-Amino-2-deoxy--D-glucopyranose hydrochloride[66-84-2].

» Glucosamine Hydrochloride contains not less than 98.0 percent and not more than 102.0percent of C6H13NO5·HCl, calculated on the dried basis.

Packaging and storage—Preserve in tight, light-resistant containers.

USP REFERENCE STANDARDS 11—

USP Glucosamine Hydrochloride RS

Identification—

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 thechromatogram of the Standard preparation, as obtained in the Assay.

PECIFICROTATION781S: between +70.0 and +73.0.

Test solution: 25 mg per mL, in water.

Measure the specific rotation 3 hours after sample preparation.

PH .791:between 3.0 and 5.0, in a solution containing 20 mg per mL.

LOSS ON DRYING 731—Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.

RESIDUE ON IGNITION 281: not more than 0.1%.

SULFATE 221—A 0.10-g portion shows no more sulfate than corresponds to 0.25 mL of 0.020 N sulfuric acid:not more than 0.24% is found.

付费版美国药典文件

2011-1-10USP-NF

ARSENIC, Method II 211: 3 µg per g.

HEAVY METALS, Method II 231: 0.001%.

Change to read:

Assay—

Diluent—Prepare a mixture of acetonitrile and water (50:50).

Phosphate buffer—In a 2-L volumetric flask, dissolve 7.0 g of dibasic potassium phosphate in water, add 0.5 mLof ammonium hydroxide, dilute with water to volume, and mix. Adjust with phosphoric acid to a pH of 7.5.Mobile phase—Prepare a mixture of acetonitrile and Phosphate buffer (75:25). Make adjustments if necessary(see System Suitability under Chromatography 621).

Standard preparation—Dissolve an accurately weighed quantity of USP Glucosamine Hydrochloride RS inDiluent to obtain a solution having a known concentration of about 3.75 mg per mL. Shake for 5 minutes bymechanical means to allow for complete dissolution.

Assay preparation—Transfer about 187.5 mg of Glucosamine Hydrochloride, accurately weighed, to a 50-mLvolumetric flask. Dissolve in 25 mL of Diluent, and shake by mechanical means. Dilute with Diluent to volume,and mix.

Chromatographic system (see HROMATOGRAPHY621)—The liquid chromatograph is equipped with a 195-nmdetector and a 4.6-mm × 15-cm column that contains 5-µm packing L8. The flow rate is about 1.5 mL per minute.The column is maintained at a temperature of 35. Chromatograph the Standard preparation, and record the peakresponses as directed for Procedure: the tailing factor for the glucosamine peak is not more than 2.0; thecolumn efficiency is not less than 1500 theoretical plates; and the relative standard deviation for replicateinjections is not more than 2.0%.

Procedure—Separately inject equal volumes (about 10 µL) of the Standard preparation and 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:

5,000(C/W)(rU / rS)

in which C is the concentration, in mg per mL, of USP Glucosamine Hydrochloride RS in the Standardpreparation; W is the weight, in mg, of Glucosamine Hydrochloride used to prepare the Assay preparation; andrU and rS are the peak responses obtained from the Assay preparation and the Standard preparation,

respectively.1S (USP32)

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/QuestionContact

Monograph

1-301-816-8540

Reference

StandardsLili Wang, Technical ServicesScientist

1-301-816-8129

Expert Committee(DSN05) Dietary Supplements - Non-Botanicals

USP32–NF27 Page 1029

USP32–NF27 Supplement : No. 1 Page 4016

Pharmacopeial Forum: Volume No. 33(4) Page 691

Chromatographic Column—

付费版美国药典文件

2011-1-10USP-NF

GLUCOSAMINE HYDROCHLORIDE

Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.