Glucosamine, Chondroitin Sulfate Sodium, and Methylsulfonylmethane Tablets
» Glucosamine, Chondroitin Sulfate Sodium, 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 Chondroitin Sulfate Sodium and Methylsulfonylmethane. Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amounts of chondroitin sulfate sodium and glucosamine (C6H13NO5) and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of methylsulfonylmethane (C2H6O2S).
note—Chondroitin Sulfate Sodium is extremely hygroscopic once dried. Avoid exposure to atmosphere, and weigh promptly.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label indicates the types of glucosamine salts contained in the article and the species source from which chondroitin was derived. Label it to state the source(s) of chondroitin sulfate sodium, whether bovine, porcine, avian, or a mixture of any of them. The label states on the front panel the content of chondroitin sulfate sodium on the dried basis.
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: Standard solutions—Prepare as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium.
Test solution— Prepare as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium Tablets.
Procedure (see Electrophoresis 726)— Proceed as directed for Electrophoretic purity under Chondroitin Sulfate Sodium (presence of chondroitin sulfate).
C: 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.
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.
Determine the amount of chondroitin sulfate sodium dissolved by employing the following method.
Cetylpyridinium chloride solution, Diluent, and Test solution— Prepare as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium Tablets.
Standard solutions— Prepare as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium.
Procedure— Proceed as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium Tablets, adjusting the volume of the sample and/or the concentrations of the standards, if necessary. Calculate the quantity, in mg, of chondroitin sulfate sodium dissolved by the formula:
900C
in which C is the concentration, in mg per mL, of chondroitin sulfate sodium in the solution under test.
Tolerances— Not less than 75% of the labeled amount of chondroitin sulfate sodium 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 chondroitin sulfate sodium—
Cetylpyridinium chloride solution, Diluent, Test solution, and Procedure— Proceed as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium Tablets.
Standard solutions— Prepare as directed in the test for Content of chondroitin sulfate sodium under Chondroitin Sulfate Sodium.
Content of methylsulfonylmethane—
Diluent, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Methylsulfonylmethane.
Assay preparation and Procedure— Prepare 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 1138