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Documents

1.03789

SAFC

Saccharose

EMPROVE® EXPERT, Ph. Eur., ChP, JP, NF

Fabrication pharma

Synonyme(s) :

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

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About This Item

Formule empirique (notation de Hill):
C12H22O11
Numéro CAS:
57-50-1
Poids moléculaire :
342.30
Numéro Beilstein :
90825
Numéro MDL:
MFCD00006626
Code UNSPSC :
12352201

Agence

ChP
JP
NF
Ph. Eur.

Niveau de qualité

500

Gamme de produits

EMPROVE® EXPERT

Forme

solid

Caractéristiques

RNase and DNase free

Impuretés

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

Pf

185-187 °C (lit.)

Application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

Conditions d'expédition

ambient

Température de stockage

2-30°C

Chaîne SMILES 

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

Clé InChI

CZMRCDWAGMRECN-UGDNZRGBSA-N

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Description générale

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.

Informations légales

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

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable

Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Consulter la Bibliothèque de documents

Daniel Weinbuch et al.
Pharmaceutical research, 34(12), 2910-2921 (2017-10-27)
To investigate the effect of nanoparticulate impurities (NPIs) isolated from pharmaceutical-grade sucrose, on the stability of monoclonal antibodies (mAbs). NPIs were purified from pharmaceutical-grade sucrose and spiked into trastuzumab, rituximab, infliximab, and cetuximab formulations. The stability of the mAbs as
Daniel Weinbuch et al.
Pharmaceutical research, 32(7), 2419-2427 (2015-01-30)
In the present study we investigated the root-cause of an interference signal (100-200 nm) of sugar-containing solutions in dynamic light scattering (DLS) and nanoparticle tracking analysis (NTA) and its consequences for the analysis of particles in biopharmaceutical drug products. Different

Articles

Use of Stabilizers and Surfactants to Prevent Protein Aggregation

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

Protocoles

Low NPI Sucrose for Biopharmaceutical Formulations

This article describes a purification process resulting in low nanoparticulate impurities sucrose, enabling more stable protein formulations.

Contenu apparenté

Formulation

Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.

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