PHR1698

Neotame

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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

Description

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

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H315,H319
• Precautionary Statements: P264 - P280 - P302 + P352 - P305 + P351 + P338 - P332 + P313 - P337 + P313
• 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