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103789 SAFC

Sucrose

Emprove® Expert, low in nanoparticles

Synonym: α-D-Glc-(1→2)-β-D-Fru, α-D-Glucopyranosyl β-D-fructofuranoside, β-D-Fructofuranosyl-α-D-glucopyranoside, D(+)-Saccharose, Sugar

  • CAS Number 57-50-1

  • Empirical Formula (Hill Notation) C12H22O11

  • Molecular Weight 342.30

  •  Beilstein/REAXYS Number 90825

  •  MDL number MFCD00006626

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Stabilizers,
Agency/Method   ChP
  JP
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Expert
impurities   ≤0.3 IU/g endotoxin (low)
pH   7 (20 °C, 100 g/L in H2O)
mp   185-187 °C (lit.)
bulk density   800‑950 kg/m3
shipped in   ambient
storage temp.   20-25°C
SMILES string   OC[C@H]1O[C@H](O[C@]2(CO)O[C@H](CO)[C@@H](O)[C@@H]2O)[C@H](O)[C@@H](O)[C@@H]1O
InChI   1S/C12H22O11/c13-1-4-6(16)8(18)9(19)11(21-4)23-12(3-15)10(20)7(17)5(2-14)22-12/h4-11,13-20H,1-3H2/t4-,5-,6-,7-,8+,9-,10+,11-,12+/m1/s1
InChI key   CZMRCDWAGMRECN-UGDNZRGBSA-N

Description

General description

Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process - for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules. Specifically developed for high-risk applications, they are low in bioburden and endotoxins.

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

Sucrose is used as a stabilizer for the formulation of biomolecules.
We have developed a new filtration-based manufacturing process leading to a sucrose grade with unique quality characteristics: Sucrose Emprove® EXPERT Ph Eur, ChP, JP, NF is low in endotoxins and has extensively reduced levels of nanoparticulate impurities which can negatively influence the stability of biomolecule formulations, making it the ideal choice for your high-risk applications.

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Packaging

1 kg in plastic bottle

12 kg in plastic bucket

25 kg in plastic drum

Legal Information

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

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

Safety & Documentation

Safety Information

WGK Germany 
WGK 1
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

Emprove® Dossiers

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What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Three document types are included with an Emprove® Program subscription:

  • Material Qualification Dossiers
  • Quality Management Dossiers
  • Operational Excellence Dossiers

Learn more about the benefits an Emprove® Program subscription can provide

Protocols & Articles

Related Content

Formulation of Biomolecules

We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules.  Chemicals play an important role in the stabilization of a biologic drug ...
Keywords: Buffers, Chromatography

Protein Stabilizers

Explore our range of high-quality stabilizers and select the right product to successfully formulate your biomolecules and get more control over your stabilization challenges. During its manufacturin...

Peer-Reviewed Papers
15

References

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