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Safety Information

1.07071

SAFC

Neotame

EMPROVE® ESSENTIAL, NF

Pharma Manufacturing

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C20H30N2O5
CAS Number:
Molecular Weight:
378.46
Beilstein:
8352678
MDL number:
UNSPSC Code:
85151701

grade

GMP
Halal
Kosher

Quality Level

Agency

NF

description

GMO free

product line

EMPROVE® ESSENTIAL

form

fine powder

mp

80-83 °C

application(s)

pharmaceutical
solid formulation

storage temp.

15-25°C

SMILES string

COC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(O)=O)NCCC(C)(C)C

InChI

1S/C20H30N2O5/c1-20(2,3)10-11-21-15(13-17(23)24)18(25)22-16(19(26)27-4)12-14-8-6-5-7-9-14/h5-9,15-16,21H,10-13H2,1-4H3,(H,22,25)(H,23,24)/t15-,16-/m0/s1

InChI key

HLIAVLHNDJUHFG-HOTGVXAUSA-N

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General description

As a high-intensity sweetener with an excellent stability and a clean, sugar-like taste profile, neotame is your ideal tool for taste optimization. Due to its exceptional sweetness with a factor 8,000 to 13,000 greater than sucrose and 40-60 greater than aspartame, it is efficient in use and costs.
Neotame is part of our Emprove® Program and offered with extensive documentation facilitating compliance of your pharma product, full supply chain transparency and risk mitigation. The product withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

From orally disintegrating tablets (ODTs), effervescent tablets to syrups and oral films – neotame can be applied to a wide range of pharmaceutical products and enables safe and heat-stable formulations.

Features and Benefits

  • Excellent sugar-like taste profiles
  • Masking bitter aftertaste and medical off-notes with ease
  • High sweetness potency offers improved cost-efficiency
  • Enhanced stability
  • Non-cariogenic and suitable for diabetics and patients with phenylketonuria

Packaging

1070711000 / 1 kg / Polyethylene bottle
1070710250 / 250 g / Polyethylene bottle
1070710001 / 3 x 10 g / PE bottles (in cardboard box)

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

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

1070711000BWT:
CO1E1070711000:
1070710250BWT:
1070710000:
1070719020BWT:
CO1E1070710250:
1070719020:
1070710010:
1070711000:
1070710001:
CO1I1070710250:
1070710250:


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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Articles

Medicine for children poses unique formulation challenges compared to adults. Consider developmental physiology and age specifics when designing pharmaceuticals. Quality issues can severely impact patient safety. Therefore, excipient quality, supplier selection, and supply chain security are crucial, particularly for pediatric formulations.

Related Content

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

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

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