2、e contains not less than 98.0 percent and not more than 102.0 percent of (C6H14NO5)2SO4·2NaCl calculated on the dried basis.Packaging and storage— Preserve in tight, light-resistant containers. USP Reference standards 11— USP Glucosamine Hydrochloride RS . Identification
3、— A: Infrared Absorption 197K. Test solution— Transfer about 50 mg of Glucosamine Sulfate Sodium Chloride to a centrifuge tube, and dissolve in 2 mL of water. Add about 0.5 mL of barium chloride TS, and centrifuge. Evaporate the supernatant, and dry the residue at 105 for
4、 2 hours. The IR spectrum corresponds to that of a similar preparation of USP Glucosamine Hydrochloride RS, except that the addition of barium chloride TS is omitted. B: It meets the requirements of the tests for Chloride 191 and Sodium 191. C: The retention time of the
5、 major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. D: In the test for the Content of sulfate, after the addition of barium chloride TS, a white precipitate is formed. Speci
6、fic rotation 781S: between +50.0 and +55.0. Test solution: 35 mg per mL. 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
7、 more than 1.0% of its weight. Residue on ignition 281 : between 22.5% and 26.0%. Potassium— Acidify 5 mL of a solution (1 in 20) with 6 N acetic acid, and add 5 drops of sodium cobaltinitrite TS: no precipitate is formed. Arsenic, Method II 211 : 3 µg per g. Heavy met
8、als, Method II 231 : 0.001%. Content of sulfate— Transfer about 1 g of Glucosamine Sulf
