Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
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 2 hours. The IR spectrum corresponds to a similar preparation of
USP Glucosamine Hydrochloride RS, with the addition of
barium chloride TS being omitted.
C:
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Specific rotation 781S:
between +52.0
and +54.0
.
Test solution:
35 mg per mL.
pH 791:
between 3.0 and 5.0, in a solution containing 20 mg per mL.
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.
Content of sulfate—
Transfer about 1 g of Glucosamine Sulfate Sodium Chloride, 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 TS 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 added 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 sulfate 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 Hydrochloride. Calculate the percentage of (C
6H
14NO
5)
2SO
4·2NaCl 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 chloride and 431.26 is twice the molecular weight of glucosamine HCl;
W is the weight, in mg, of Glucosamine Sulfate Sodium Chloride used to prepare the
Assay preparation; and the others terms are as defined therein.
-D-glucopyranose) sulfate sodium chloride complex (-,-)