氨基葡萄糖硫酸钠盐USP32标准

氨基葡萄糖硫酸钠盐U S P32标准

Glucosamine Sulfate Sodium Chloride

(C6H14NO5)2SO4·2NaCl 573.31

Bis(d-Glucose, 2-amino-2-deoxy-), sulfate sodium chloride complex.

Bis(2-Amino-2-deoxy- -d-glucopyranose) sulfate sodium chloride complex (-,-) [38899-05-7].

» Glucosamine Sulfate Sodium Chloride contains not less than 98.0 percent a nd 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—

A: Infrared Absorption 197K.

Test solution— Transfer about 50 mg of Glucosamine Sulfate Sodium Chlorid e to a centrifuge tube,

and dissolve in 2 mL of water. Add about 0.5 mL of barium chloride TS, and c entrifuge.

Evaporate the supernatant, and dry the residue at 105 for 2 hours. The IR spe ctrum 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 major peak in the chromatogram of the Assay pre paration corresponds

to that in the chromatogram of the Standard preparation, as obtained in the As say.

D: In the test for the Content of sulfate, after the addition of barium chloride T S, a white

precipitate is formed.

Specific rotation 781S: between +50.0 and +55.0.

Test solution: 35 mg per mL. Measure the specific rotation 3 hours after sampl e 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 : 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 metals, Method II 231 : 0.001%.

Content of sulfate— Transfer about 1 g of Glucosamine Sulfate Sodium Chlori de, accurately weighed, to a 250-mL beaker, and dissolve in about 100 mL of water. Add 4 mL of 6 N hydrochloric acid. Heat the solution

to boiling, and add, with constant stirring, sufficient boiling barium chloride T S to completely precipitate the sulfate.

Add an additional 2 mL of barium chloride TS, and digest on a steam bath for 1 hour. Pass the mixture

through ashless filter paper, transferring the residue quantitatively to the filter, and wash the residue with

hot water until no precipitate is obtained when 1 mL of silver nitrate TS is add ed to 5 mL of washing.

Transfer the paper containing the residue to a tared crucible. Char the paper, without burning, and ignite

the crucible and its contents to constant weight. Calculate the content of sulfat e by multiplying the weight

obtained by 0.4116. The content of sulfate is between 16.3% and 17.3%. Assay—

Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed as

directed in the Assay under Glucosamine Hydrochloride.

Assay preparation— Transfer about 100 mg of Glucosamine Sulfate Sodium Chloride, 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.

Procedure— Proceed as directed in the Assay under Glucosamine Hydrochlor ide. Calculate the

percentage of (C6H14NO5)2SO4·2NaCl in the portion of Glucosamine Sulfate Sodium Chloride taken

by the formula:

10,000(573.31/431.26)(C / W)(rU / rS)

in which 573.31 is the molecular weight of the glucosamine sulfate sodium chl oride and 431.26 is

twice the molecular weight of glucosamine HCl; W is the weight, in mg, of Glu cosamine Sulfate

Sodium Chloride used to prepare the Assay preparation; and the others terms are as defined therein.

Auxiliary Information— Please check for your question in the FAQs before con