Glucosamine and Methylsulfonylmethane Tablets
» Glucosamine and Methylsulfonylmethane Tablets are prepared from either Glucosamine Hydrochloride, Glucosamine Sulfate Sodium Chloride, Glucosamine Sulfate Potassium Chloride, or a mixture of any of them, with Methylsulfonylmethane. Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of glucosamine (C6H13NO5) and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of methylsulfonylmethane (C2H6O2S).
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label indicates the types of glucosamine salts contained in the article.
Identification—
A: The retention times of the major peaks in the chromatogram of the Test solution correspond to those in the chromatogram of the Standard solution, as obtained in the test for Content of glucosamine (presence of glucosamine) under Glucosamine and Chondroitin Sulfate Sodium Tablets.
B: The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the test for Content of methylsulfonylmethane under Methylsulfonylmethane Tablets.
Disintegration and dissolution 2040: meet the requirements for Dissolution.
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 60 minutes.
Determine the amount of glucosamine (C6H13NO5) dissolved by employing the following method.
Diluent, 0.2 M Borate buffer, Derivatizing reagent, Mobile phase, and Chromatographic system— Proceed as directed in the test for Content of glucosamine.
Standard solution— Prepare as directed in the test for Content of glucosamine. Dilute with a suitable quantity of water, if necessary.
Test solution— Use the solution under test.
Procedure— Proceed as directed in the test for Content of glucosamine. Calculate the quantity, in mg, of glucosamine (C6H13NO5) dissolved by the formula:
(179.17/215.63)(900C)(rU / rS)
in which the terms are as defined therein.
Tolerances— Not less than 75% of the labeled amount of C6H13NO5 is dissolved in 60 minutes.
Weight variation 2091: meet the requirements.
Content of glucosamine—
Diluent, 0.2 M Borate buffer, Derivatizing reagent, Mobile phase, Standard solution, Test solution, Chromatographic system, and Procedure— Proceed as directed in the test for Content of glucosamine under Glucosamine and Chondroitin Sulfate Sodium Tablets.
Content of methylsulfonylmethane—
Diluent, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Methylsulfonylmethane.
Assay preparation and Procedure— Proceed as directed in the Assay under Methylsulfonylmethane Tablets.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Curtis Phinney

1-301-816-8540
(DSN05) Dietary Supplements - Non-Botanicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 1032
Pharmacopeial Forum: Volume No. 32(4) Page 1137
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.