Glucosamine Hydrochloride
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C6H13NO5·HCl 215.63
d-Glucose, 2-amino-2-deoxy-, hydrochloride;    
2-Amino-2-deoxy--d-glucopyranose hydrochloride     [66-84-2].
Glucosamine Hydrochloride contains NLT 98.0% and NMT 102.0% of glucosamine hydrochloride (C6H13NO5·HCl), calculated on the dried basis.
•  B. Identification Tests—General, Chloride 191: Meets the requirements
•  C. The retention time of the glucosamine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
•  Procedure
Buffer:  In a 1-L volumetric flask, dissolve 3.5 g of dibasic potassium phosphate in water. Add 0.25 mL of ammonium hydroxide, dilute with water to volume, and mix. Adjust with phosphoric acid to a pH of 7.5.
Mobile phase:  Acetonitrile and Buffer (75:25)
Diluent:  Acetonitrile and water (50:50)
Standard solution:  3.8 mg/mL of USP Glucosamine Hydrochloride RS in Diluent
Sample solution:  3.8 mg/mL of Glucosamine Hydrochloride in Diluent. [Note—Shake by mechanical means to aid dissolution. ]
Chromatographic system 
Mode:  LC
Detector:  UV 195 nm
Column:  4.6-mm × 15-cm; 5-µm packing L8
Column temperature:  35
Flow rate:  1.5 mL/min
Injection size:  10 µL
System suitability 
Sample:  Standard solution
[Note—The peak for the glucosamine moiety elutes at about 10 min. The chromatogram shows a large additional peak near the void volume, due to the chloride ion. ]
Suitability requirements 
Tailing factor:  NMT 2.0 for the glucosamine peak
Efficiency:  NLT 1500 theoretical plates
Relative standard deviation:  NMT 2.0%
Samples:  Standard solution and Sample solution
Calculate the percentage of glucosamine hydrochloride (C6H13NO5·HCl) in the portion of Glucosamine Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU== peak response from the Sample solution
rS== peak response from the Standard solution
CS== concentration of USP Glucosamine Hydrochloride RS in the Standard solution (mg/mL)
CU== concentration of Glucosamine Hydrochloride in the Sample solution (mg/mL)
Acceptance criteria:  98.0%–102.0% on the dried basis
•  Residue on Ignition 281: NMT 0.1%
•  Chloride and Sulfate, Sulfate 221: A 0.10-g portion shows no more sulfate than corresponds to 0.25 mL of 0.020 N sulfuric acid (NMT 0.24%).
•  Arsenic, Method II 211: NMT 3 ppm
•  Heavy Metals, Method II 231: NMT 10 ppm
•  Optical Rotation, Specific Rotation 781S: +70.0 to +73.0
Sample solution:  25 mg/mL. Measure the specific rotation 3 h after preparation.
•  pH 791
Sample solution:  20 mg/mL
Acceptance criteria:  3.0–5.0
•  Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight.
•  Packaging and Storage: Preserve in tight, light-resistant containers.
•  USP Reference Standards 11
USP Glucosamine Hydrochloride RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Huy T. Dinh, M.S.
Scientific Liaison
(DS2010) Monographs - Dietary Supplements
Reference Standards RS Technical Services
USP35–NF30 Page 1334
Pharmacopeial Forum: Volume No. 33(4) Page 691