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Merck

1.03789

SAFC

Sucrose

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

Produkcja farmaceutyczna

Synonim(y):

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

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About This Item

Wzór empiryczny (zapis Hilla):
C12H22O11
Numer CAS:
Masa cząsteczkowa:
342.30
Beilstein:
90825
Numer MDL:
Kod UNSPSC:
12352201

agency

ChP
JP
NF
Ph. Eur.

Poziom jakości

linia produktu

EMPROVE® EXPERT

Postać

solid

Właściwości

RNase and DNase free

zanieczyszczenia

≤0.3 IU/g endotoxin (low)

pH

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

Zastosowanie

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

Warunki transportu

ambient

temp. przechowywania

2-30°C

ciąg 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

Klucz InChI

CZMRCDWAGMRECN-UGDNZRGBSA-N

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Opis ogólny

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.

Zastosowanie

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.

Informacje prawne

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

11 - Combustible Solids

Klasa zagrożenia wodnego (WGK)

WGK 1

Temperatura zapłonu (°F)

Not applicable

Temperatura zapłonu (°C)

Not applicable


Certyfikaty analizy (CoA)

Poszukaj Certyfikaty analizy (CoA), wpisując numer partii/serii produktów. Numery serii i partii można znaleźć na etykiecie produktu po słowach „seria” lub „partia”.

Masz już ten produkt?

Dokumenty związane z niedawno zakupionymi produktami zostały zamieszczone w Bibliotece dokumentów.

Odwiedź Bibliotekę dokumentów

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
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

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