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Documentos Principais

PHR1698

Supelco

Neotame

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Neotame monohydrate, N-[N-(3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester monohydrate

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About This Item

Fórmula empírica (Notação de Hill):
C20H30N2O5 · H2O
Número CAS:
Peso molecular:
396.48
Código UNSPSC:
41116107
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. 1460204

família API

neotame

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

2-30°C

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Descrição geral

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.

Aplicação

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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Produtos recomendados

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.

Pictogramas

Exclamation mark

Palavra indicadora

Warning

Frases de perigo

Classificações de perigo

Eye Irrit. 2 - Skin Irrit. 2

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Certificados de análise (COA)

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Visite a Biblioteca de Documentos

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)
Handbook of Pharmaceutical Excipients (2009)

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