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-b-D-glucopyranose)sulfate sodium chloride complex (-,-) [38899-05-7].
»Glucosamine Sulfate Sodium Chloride contains not less than 98.0percent and not more than 102.0percent of (C6H14NO5)2SO4·2NaCl calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: Infrared Absorption á197Kñ.
Test solution— Transfer about 50mg of Glucosamine Sulfate Sodium Chloride to a centrifuge tube,and dissolve in 2mLof water.Add about 0.5mLof barium chloride TS,and centrifuge.Evaporate the supernatant,and dry the residue at 105for 2hours.The IRspectrum corresponds to a similar preparation of USP Glucosamine Hydrochloride RS,with the addition of barium chloride TSbeing omitted.
B: It meets the requirements of the tests for Chloride á191ñ,Sodium á191ñ,and Sulfate á191ñ.
C: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Specific rotation á781Sñ: between +52.0and +54.0.
Test solution: 35mg per mL.
pHá791ñ: between 3.0and 5.0,in a solution containing 20mg per mL.
Loss on drying á731ñ— Dry it at 105for 2hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ: between 23.5%and 25.0%.
Potassium— Acidify 5mLof a solution (1in 20)with 6Nacetic acid,and add 5drops of sodium cobalt nitrite TS:no precipitate is formed.
Content of sulfate— Transfer about 1g of Glucosamine Sulfate Sodium Chloride,accurately weighed,to a 250-mLbeaker,and dissolve in about 100mLof water.Add 4mLof 6Nhydrochloric acid.Heat the solution to boiling,and add,with constant stirring,sufficient boiling barium chloride TSto completely precipitate the sulfate.Add an additional 2mLof barium chloride TS,and digest on a steam bath for 1hour.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 1mLof silver nitrate TSis added to 5mLof 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 Assayunder Glucosamine Hydrochloride.
Assay preparation— Transfer about 100mg of Glucosamine Sulfate Sodium Chloride,accurately weighed,to a 100-mLvolumetric flask.Dissolve in 30mLof water,shake by mechanical means,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Glucosamine Hydrochloride.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 573.31is the molecular weight of the glucosamine sulfate sodium chloride and 431.26is twice the molecular weight of glucosamine HCl;Wis the weight,in mg,of Glucosamine Sulfate Sodium Chloride used to prepare the Assay preparation;and the others terms are as defined therein.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 2101
Phone Number:1-301-816-8389