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PHR1698

Supelco

Neotame

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Neotame monohydrate, N-[N-(3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester monohydrate
Empirical Formula (Hill Notation):
C20H30N2O5 · H2O
CAS Number:
243116-62-3
Molecular Weight:
396.48
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. 1460204

API family

neotame

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

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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. 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

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).
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.

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.

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.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H319

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2

WGK

WGK 3

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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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)

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