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Merck
CN

1.00895

SAFC

Sucralose

granular, EMPROVE® ESSENTIAL, Ph. Eur., JPE, NF

Pharma Manufacturing

Synonym(s):

Sucralose, 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside, E955, Trichlorosucrose

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About This Item

Empirical Formula (Hill Notation):
C12H19Cl3O8
CAS Number:
Molecular Weight:
397.63
Beilstein:
3654410
MDL number:
UNSPSC Code:
12352121
EC Index Number:
259-952-2

Agency

JPE
NF
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

fine powder
granular

particle size

≥80 μm (d90)

pH

6-8 (20 °C, 100 g/L in H2O)

mp

130 °C (decomposition)

density

1.62 g/cm3 at 20 °C

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

15-25°C

SMILES string

OC[C@H]1O[C@H](O[C@]2(CCl)O[C@H](CCl)[C@@H](O)[C@@H]2O)[C@H](O)[C@@H](O)[C@H]1Cl

InChI

1S/C12H19Cl3O8/c13-1-4-7(17)10(20)12(3-14,22-4)23-11-9(19)8(18)6(15)5(2-16)21-11/h4-11,16-20H,1-3H2/t4-,5-,6+,7-,8+,9-,10+,11-,12+/m1/s1

InChI key

BAQAVOSOZGMPRM-QBMZZYIRSA-N

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Sucralose is a high-intensity sweetener which is non-cariogenic and suitable for diabetics and patients with an impaired glucose tolerance. In addition, it is readily soluble and masks both bitterness and medicinal off-notes with equal ease – making it exceptionally well-suited for pharmaceutical applications.
Our Sucralose is available in micronized or granular form, both pharmaceutical grade, allowing you to choose depending on your individual needs. Due to its optimal dispersion behavior, sucralose powder is typically recommended for solid dose formulations, while the fast dissolution behavior of sucralose granular makes it very well-suited for liquid formulations.

Biochem/physiol Actions

A synthetic sweet tastant detectable by humans. Activates T1R2/T1R3 sweet taste receptors on enteroendocrine cells and elicits increased hormonal secretion of glucagon-like peptide-1 and glucose-dependent insulinotrophic peptide.

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

Legal Information

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

Disclaimer

The substance 1.00895 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

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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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.

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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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