N-乙酰氨基葡萄糖-USP38

USP 38Dietary Supplements / N-Acetylglucosamine5865 Dietary Supplements

Official Monographs

[N OTE—The relative retention times for N-acetyl-

glucosamine and glucosamine are 1.0 and about 2.8, N-Acetylglucosamine

respectively.]

Suitability requirements

Signal-to-noise ratio: NLT 10 for the glucosamine

peak, System suitability solution

Resolution: NLT 5.0 between the N-acetyl-

glucosamine and glucosamine peaks, System suitabil-

ity solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 2.0%, Standard

solution

C8H15NO6221.21Analysis

2-(Acetylamino)-2-deoxy-D-glucose;Samples:Standard solution and Sample solution

N-Acetyl-D-Glucosamine [7512-17-6].Calculate the percentage of N-acetylglucosamine

(C8H15NO6) in the portion of N-Acetylglucosamine DEFINITION taken:

N-Acetylglucosamine contains NLT 98.0% and NMT 102.0%

of N-acetylglucosamine (C8H15NO6), calculated on the Result = (r

U/r S) × (C S/C U) × 100

dried basis.

r U= peak response from the Sample solution IDENTIFICATION r

S= peak response from the Standard solution •A. I NFRARED A BSORPTION〈197K〉C

S= concentration of USP N-Acetylglucosamine RS •B. It meets the requirements in the test for Optical Rota-in the Standard solution (mg/mL) tion 〈781S〉, Specific Rotation.C

U= concentration of N-Acetylglucosamine in the •C. The retention time of the major peak of the Sample Sample solution (mg/mL) solution corresponds to that of the Standard solution, as Acceptance criteria: 98.0%–102.0% on the dried basis obtained in the Assay.

IMPURITIES

ASSAY•R ESIDUE ON I GNITION〈281〉: NMT 0.1%

•P ROCEDURE•C HLORIDE AND S ULFATE, Chloride〈221〉: NMT 0.1% Buffer: Transfer 3.5g of dibasic potassium phosphate to•E LEMENTAL I MPURITIES—P ROCEDURES〈233〉

a 1-L volumetric flask, and add sufficient water to dis-Acceptance criteria

solve. Add 0.25mL of ammonium hydroxide, dilute Arsenic: NMT 1µg/g

with water to volume, and mix. Adjust with phosphoric Lead: NMT 10µg/g

acid to a pH of 7.5.•R ELATED C OMPOUNDS

Mobile phase: Acetonitrile and Buffer (75:25)Buffer, Mobile phase, Diluent, System suitability solu-Diluent: Acetonitrile and water (50:50)tion, Chromatographic system, and System suitabil-System suitability solution: 1.0mg/mL of USP N-ity: Proceed as directed in the Assay.

Acetylglucosamine RS and 0.6mg/mL of USP Glucosa-Sample solution: 2.5mg/mL of N-Acetylglucosamine in mine Hydrochloride RS in Diluent Diluent

Standard solution: 1.0mg/mL of USP N-Acetyl-Analysis

glucosamine RS in Diluent Sample:Sample solution

Sample solution: 1.0mg/mL of N-Acetylglucosamine in Calculate the percentage of each impurity in the por-Diluent tion of N-Acetylglucosamine taken:

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)Result = (r

U/r T) × 100 Mode: LC

Detector: UV 195 nm r U= peak response of each impurity from the Column: 4.6-mm × 15-cm; 3-µm packing L8Sample solution

Column temperature: 35°r T= sum of the peak responses from the Sample Flow rate: 1.5mL/min solution

Injection volume: 10µL

System suitability

Samples:System suitability solution and Standard

solution