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Analysis of Glucosamine According to USP-NF Method (5NH 4D)


According to the United States Pharmacopeia and the National Formulary (USP 39-NF 34*), analysis of glucosamine hydrochloride should be carried out with a column filled with L8 packing material and meets following requirements. The Silica 5NH 4D confirmed the requirements were met.

System suitability requirements:
 Theoretical plate number: ≥ 1,500
 Relative standard deviation (RSD): ≤ 2.0%
 Tailing factor: ≤ 2.0

*The version at the time of the application acquisition. 

Sample :  10 μL
3.8 mg/mL
Glucosamine hydrochloride
(in H2O/CH3CN=1/1)
1. Cl-
2. Glucosamine

Column       : Shodex Silica 5NH 4D (4.6 mm I.D. x 150 mm)
Eluent       : *Buffer(pH7.5)/CH3CN=30/70 
               *Buffer ; in a 1-L volumetric flask, dissolve 3.5 g K2HPO4 in water. 
               Add 0.25 mL Ammonium hydroxide (25 %), dilute with water to volume, and mix. 
               Adjusted with H3PO4 to a pH7.5
Flow rate    : 1.1 mL/min
Detector     : UV (195 nm)
Column temp. : 35 °C

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