Glucosamine Hydrochloride
C6H13NO5·HCl 215.63
d-Glucose, 2-amino-2-deoxy-, hydrochloride;
2-Amino-2-deoxy-
-d-glucopyranose hydrochloride
[66-84-2].
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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].DEFINITION
Glucosamine Hydrochloride contains NLT 98.0% and NMT 102.0% of glucosamine hydrochloride (C6H13NO5·HCl), calculated on the dried basis.
IDENTIFICATION
• B. Identification Tests—General, Chloride 
191
:
Meets the requirements
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.
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%
Analysis
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
IMPURITIES
• Residue on Ignition 281:
NMT 0.1%
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%).
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
211:
NMT 3 ppm
• Heavy Metals, Method II 231:
NMT 10 ppm
231:
NMT 10 ppm
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S:
+70.0 to +73.0
781S:
+70.0 to +73.0
Sample solution:
25 mg/mL. Measure the specific rotation 3 h after preparation.
• Loss on Drying 731:
Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight.
731:
Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• USP Reference Standards 11
11
USP Glucosamine Hydrochloride RS 
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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 1-301-816-8594 |
(DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1334
Pharmacopeial Forum: Volume No. 33(4) Page 691