Merck
Todas as fotos(5)

1.03789

SAFC

Sucrose

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

Sinônimo(s):
D(+)-Saccharose, α-D-Glc-(1→2)-β-D-Fru, α-D-Glucopyranosyl β-D-fructofuranoside, Sugar, β-D-Fructofuranosyl-α-D-glucopyranoside
Empirical Formula (Hill Notation):
C12H22O11
Número CAS:
Peso molecular:
342.30
Beilstein:
90825
Número MDL:

Nível de qualidade

500

Agency

ChP
JP
NF
Ph. Eur.

linha de produto

EMPROVE® EXPERT

forma

solid

Impurezas

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

pf

185-187 °C (lit.)

application(s)

biopharma process and formulation
liquid formulation
parenterals
pharmaceutical

enviado em

ambient

temperatura de armazenamento

2-30°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

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Descrição geral

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.

Aplicação

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.

Informações legais

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

Código de classe de armazenamento

11 - Combustible Solids

WGK

WGK 1

Ponto de fulgor (ºF)

Not applicable

Ponto de fulgor (ºC)

Not applicable

Certificado de análise

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Certificado de qualidade

Digite o número do lote para pesquisar o certificado de qualidade (CoQ).

O que é o Programa Emprove®?

O programa Emprove® é um sistema que fornece documentação completa e aprofundada sobre os nossos filtros e componentes descartáveis, matérias-primas para a indústria farmacêutica e materiais de partida.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Saiba mais sobre os benefícios uma assinatura do Programa Emprove® pode fornecer
Por que esses documentos não estão disponíveis?
Os dossiês Emprove® contêm informações destinadas a auxiliar no processo de registro e nas atividades de avaliação de risco dos produtores de fármacos e contêm informações confidenciais. Por favor, entre em contato conosco se desejar ter acesso.
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

Protocolos

Low-in-Nanoparticulate-Impurities Sucrose for Biopharmaceutical Formulations

Nanoparticulate impurities (NPIs) in pharmaceutical-grade sucrose reduce the stability of final protein formulations. Applying a purification process results in a low NPI sucrose, thus mitigating risk during formulation development.

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