Printed on: Mon Nov 11 2024, 14:50:56 pm
Printed by: Reem Harbi
Status: Currently Official on 11-Nov-2024
Official Date: Official as of 01-Jun-2023
Document Type: USP Monographs
DocId: GUID-A4060272-D0D3-4FFF-84AC-30A363931EAB_5_en-US
DOI: https://doi.org/10.31003/USPNF_M35284_05_01
DOI Ref: qe20d
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-A4060272-D0D3-4FFF-84AC-30A363931EAB_5_en-US
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Glutamine
C5H10N2O3 146.14
l-Glutamine;
2-Aminoglutaramic acid CAS RN®: 56-85-9; UNII: 0RH81L854J.
DEFINITION
Glutamine contains NLT 98.5% and NMT 101.5% of l-glutamine (C5H10N2O3), calculated on the dried basis.
IDENTIFICATION
• A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
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ASSAY
• Procedure
Sample: 150 mg of Glutamine
IA
Blank: Mix 3 mL of formic acid and 50 mL of glacial acetic acid.
Titrimetric system
(See Titrimetry 〈541〉.)
Mode: Direct titration
IC
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Potentiometric
Analysis: Dissolve the Sample in 3 mL of formic acid and 50 mL of glacial acetic acid, and titrate with the Titrant. Perform a Blank
determination.
FF
Calculate the percentage of glutamine (C5H10N2O3) in the Sample taken:
Result = {[(VS − VB) × N × F]/W} × 100
VS = volume of Titrant consumed by the Sample (mL)
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VB = volume of Titrant consumed by the Blank (mL)
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 146.1 mg/mEq
W = Sample weight (mg)
Acceptance criteria: 98.5%–101.5% on the dried basis
IMPURITIES
• Residue on Ignition 〈281〉: NMT 0.3%
• Chloride and Sulfate, Chloride〈221〉
Standard solution: 0.50 mL of 0.020 N hydrochloric acid
Sample: 0.7 g of Glutamine
Acceptance criteria: NMT 0.05%
• Chloride and Sulfate, Sulfate〈221〉
Standard solution: 0.25 mL of 0.020 N sulfuric acid
Sample: 0.8 g of Glutamine
Acceptance criteria: NMT 0.03%
Change to read:
• ▲Iron 〈241〉, Procedures, Procedure 1▲ (CN 1-Jun-2023): NMT 30 ppm
• Related Compounds
Standard solution: 0.05 mg/mL of USP Glutamine RS in water
Sample solution: 10 mg/mL of Glutamine in water
Chromatographic system
(See Chromatography 〈621〉, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture
Application volume: 5 µL
Developing solvent system: Butyl alcohol, glacial acetic acid, and water (3:1:1)
Spray reagent: 2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
Analysis: Dry the plate at 80° for 30 min. Spray the plate with Spray reagent, heat at 80° for 10 min, and examine under white light.
Acceptance criteria: No secondary spot of the Sample solution is larger or more intense than the principal spot of the Standard solution (NMT
0.5%).
SPECIFIC TESTS
• Optical Rotation, Specific Rotation〈781S〉
Sample solution: 40 mg/mL in water. Warm at 40° to dissolve.
Analysis: Proceed as directed in the chapter, except measure at 20°.
Acceptance criteria: +6.3° to +7.3°
• Loss on Drying 〈731〉: Dry a sample at 105° for 3 h: it loses NMT 0.3% of its weight.
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ADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in well-closed containers, and store at controlled room temperature.
IA
• USP Reference Standards 〈11〉
USP Glutamine RS
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Auxiliary Information - Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Fatkhulla K Tadjimukhamedov NBDS2020 Non-botanical Dietary
GLUTAMINE
Associate Scientific Liaison Supplements
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Chromatographic Database Information: Chromatographic Database
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Most Recently Appeared In:
Pharmacopeial Forum: Volume No. Information currently unavailable
Current DocID: GUID-A4060272-D0D3-4FFF-84AC-30A363931EAB_5_en-US
DOI: https://doi.org/10.31003/USPNF_M35284_05_01
DOI ref: qe20d
