USP Aspartame
USP Aspartame
USP Aspartame
Printed by: Rahmawati Ekaputri Official Date: Official as of 01-May-2020 Document Type: NF @2023 USPC
Do Not Distribute DOI Ref: 3s5c9 DOI: https://doi.org/10.31003/USPNF_M6195_04_01
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ASSAY Analysis
• PROCEDURE Samples: Standard solution and Sample solution
Buffer: 0.05 M monobasic potassium phosphate, adjusted [NOTE—Continue the elution of the Sample solution for
with phosphoric acid to a pH of 4.3 ci 45 min.]
Mobile phase: Methanol and Buffer (18:82) Calculate the percentage of aspartame related compound A
Diluent: Methanol and water (1:9) in the portion of Aspartame taken:
System suitability solution: 0.1 mg/mL each of USP
Aspartame Related Compound A RS and USP Result = (r U/r S) × (C S/C U) × 100
l-Phenylalanine RS in Diluent
Standard solution: 0.5 mg/mL of USP Aspartame RS in rU = peak response of aspartame related compound A
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Diluent from the Sample solution
Sample solution: 0.5 mg/mL of Aspartame in Diluent. rS = peak response of aspartame related compound A
[NOTE—Avoid heat and excessive holding times.] from the Standard solution
Chromatographic system CS = concentration of 5-benzyl-3,6-dioxo-
(See Chromatography á621ñ, System Suitability.) 2-piperazineacetic acid in the Standard solution
Mode: LC (mg/mL)
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Printed on: Mon May 08 2023, 10:21:17 PM(EST) Status: Currently Official on 09-May-2023 DocId: GUID-0B161E00-C2E8-4232-8E54-4E7AE6BF70C2_4_en-US
Printed by: Rahmawati Ekaputri Official Date: Official as of 01-May-2020 Document Type: NF @2023 USPC
Do Not Distribute DOI Ref: 3s5c9 DOI: https://doi.org/10.31003/USPNF_M6195_04_01
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