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 TestsGeneral, 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.
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. [NoteShake by mechanical means to aid dissolution. ]
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
Sample: Standard solution
[NoteThe 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. ]
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
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: 3.05.0
• 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
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1334Pharmacopeial Forum: Volume No. 33(4) Page 691