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1.37171

SAFC

TWEEN® 80

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

Produzione farmaceutica

Sinonimo/i:

Monooleato di polietilenglicole sorbitano, Monooleato di poliossietilene sorbitano, POE (20) sorbitano monooleato, Polisorbato 80

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About This Item

Numero CAS:
9005-65-6
Numero MDL:
MFCD00082107
Codice UNSPSC:
12352207
Numero indice EU:
500-019-9

Origine biologica

synthetic

Livello qualitativo

500

Grado

GDP
GMP
Halal
Kosher

agenzia

ChP
JP
NF
Ph. Eur.

Descrizione

GMO free
low in endotoxins

Nome Commerciale

EMPROVE® EXPERT

Forma fisica

liquid

Potenza

42200 mg/kg LD50, oral

PM

1310 g/mol

pH

5-7 (20 °C, 50 g/L)

P. eboll.

>100 °C

Densità

1.07 g/cm3 at 25 °C

applicazioni

liquid formulation
parenterals
pharmaceutical

Attività estranea

Aflatoxin free

Temperatura di conservazione

15-25°C

Stringa SMILE

CCCCCCCC/C=C/CCCCCCCC(=O)OCCOCC(C1C(CC(O1)OCCO)OCCO)OCCO

InChI

1S/C32H60O10/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-30(36)40-25-24-37-27-29(39-22-19-34)32-28(38-21-18-33)26-31(42-32)41-23-20-35/h9-10,28-29,31-35H,2-8,11-27H2,1H3/b10-9+
RGPBUVUVZKQNHD-MDZDMXLPSA-N

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Descrizione generale

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.

Applicazioni

Polysorbate 80 is used to stabilize biomolecule formulations and as solubilizer, emulsifier and wetting agent in small molecule formulations. Polysorbates are known to degrade via autoxidation and hydrolysis. Degradation products can have a negative impact on the stability of the protein as well as the small molecule API. To reduce this risk, the polysorbate high-purity grade contains a low amount of impurities, especially peroxide.

Intended for high-risk applications, this Emprove® Expert grade contains bioburden and endotoxin limits.

Confezionamento

1371710100 / 100ml / glass bottle
1371711000 / 1L / glass bottle

Note legali

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
TWEEN is a registered trademark of Croda International PLC

Applicazioni

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Codice della classe di stoccaggio

10 - Combustible liquids

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

235.4 °F - closed cup

Punto d’infiammabilità (°C)

> 113 °C - closed cup

Certificati d'analisi (COA)

Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.

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Articoli

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.

Strategies for the Development of Safe and Effective Pediatric Formulations

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.

Contenuto correlato

Formulation

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

Pediatric Formulations

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.

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