CN
All Photos(1)

PHR1698

Supelco

Neotame

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
N-[N-(3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester monohydrate, Neotame monohydrate
Empirical Formula (Hill Notation):
C20H30N2O5 · H2O
CAS Number:
Molecular Weight:
396.48
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Looking for similar products? Visit Product Comparison Guide

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. Neotame is a water-soluble, non-calorific, high-intensity sweetener utilized in food and beverages. Its structure resembles that of aspartame. Its sweetness potency is about 700-13000 times greater than that of sucrose and 30-60 times greater than that of aspartame. It is known as one of the sweetest artificial sweeteners.

Application

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.
Neotame may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography (LC) technique. It can also be used as a non-nutritive sweetener in chewable tablets, and the subsequent determination of the analyte can be carried out using high-performance liquid chromatography (HPLC).

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3263 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Handbook of Pharmaceutical Excipients (2009)
Neotame
USP42-NF37
United States Pharmacopeia/National Formulary, 42(3), 5841-5841 (2017)
Formulation and evaluation of sugar free sucralfate chewable tablets
World Journal of Pharmaceutical Research (2017)

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service