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PHR1381

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Aspartame

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Asp-Phe methyl ester, N-(L-α-Aspartyl)-L-phenylalanine methyl ester, Asp-Phe-OMe, Aspartame
Linear Formula:
HOOCCH2CH(NH2)CONHCH(CH2C6H5)COOCH3
CAS Number:
22839-47-0
Molecular Weight:
294.30
Beilstein:
2223850
EC Number:
245-261-3
MDL number:
MFCD00002724
UNSPSC Code:
41116107
PubChem Substance ID:
329823358
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. A1320000
traceable to USP 1043706

API family

aspartame

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

COC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](N)CC(O)=O

InChI

1S/C14H18N2O5/c1-21-14(20)11(7-9-5-3-2-4-6-9)16-13(19)10(15)8-12(17)18/h2-6,10-11H,7-8,15H2,1H3,(H,16,19)(H,17,18)/t10-,11-/m0/s1

InChI key

IAOZJIPTCAWIRG-QWRGUYRKSA-N

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Aspartame is a low-calorie nutritive sugar substitute used in table-top sweeteners, chewing gums, soft drinks, etc.

Application

Aspartame may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB9987 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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HPLC analysis of aspartame and saccharin in pharmaceutical and dietary formulations.
Di Pietra AM, et al.
Chromatographia, 30(3-4), 215-219 (1990)
Marina Marinovich et al.
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 60, 109-115 (2013-07-31)
Aspartame is a synthetic sweetener that has been used safely in food for more than 30 years. Its safety has been evaluated by various regulatory agencies in accordance with procedures internationally recognized, and decisions have been revised and updated regularly.
L D Stegink
The American journal of clinical nutrition, 46(1 Suppl), 204-215 (1987-07-01)
Toxicology is based on the premise that all compounds are toxic at some dose. Thus, it is not surprising that very large doses of aspartame (or its components--aspartate, phenylalanine, and methanol) produce deleterious effects in sensitive animal species. The critical
T J Maher et al.
Environmental health perspectives, 75, 53-57 (1987-11-01)
The artificial sweetener aspartame (L-aspartyl-L-phenylalanyl-methyl ester), is consumed, primarily in beverages, by a very large number of Americans, causing significant elevations in plasma and, probably, brain phenylalanine levels. Anecdotal reports suggest that some people suffer neurologic or behavioral reactions in
Harriett H Butchko et al.
Regulatory toxicology and pharmacology : RTP, 35(2 Pt 2), S1-93 (2002-08-16)
Over 20 years have elapsed since aspartame was approved by regulatory agencies as a sweetener and flavor enhancer. The safety of aspartame and its metabolic constituents was established through extensive toxicology studies in laboratory animals, using much greater doses than
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