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Key Documents

Safety Information

PHR1381

Supelco

Aspartame

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Asp-Phe methyl ester, N-(L-α-Aspartyl)-L-phenylalanine methyl ester, Asp-Phe-OMe, Aspartame

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About This Item

Linear Formula:
HOOCCH2CH(NH2)CONHCH(CH2C6H5)COOCH3
CAS Number:
Molecular Weight:
294.30
Beilstein:
2223850
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

PHR1381-1G:
PHR1381-1G-PW:


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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)
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
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
J D Fernstrom
Appetite, 11 Suppl 1, 35-41 (1988-01-01)
The ingestion of a meal of carbohydrates by fasting rats rapidly increases brain tryptophan level and serotonin (5-HT) synthesis. The rise in brain tryptophan level follows from an increase in tryptophan transport into brain, the consequence of an insulin-induced reduction
P J Janssen et al.
Toxicology, 50(1), 1-26 (1988-06-01)
In this report the neurotoxicity of aspartame and its constituent amino acids aspartic acid and phenylalanine is reviewed. The adverse reactions ascribed to the consumption of aspartame-containing products, as reported in the U.S.A., are discussed and placed in perspective with

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