1.37172

Polysorbate 20

high purity, EMPROVE^® EXPERT, Ph. Eur., ChP, JPE, NF

• Synonim(y): Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20
• Numer CAS: 9005-64-5
• Numer MDL: MFCD00165986
• Kod UNSPSC: 12161900
• Numer indeksu EC: 500-018-3

Właściwości

• pochodzenie biologiczne: synthetic
• Poziom jakości: 500
• klasa czystości: GDP; GMP; Halal; Kosher
• agency: ChP; JPE; NF; Ph. Eur.
• opis: GMO free; low in endotoxins
• linia produktu: EMPROVE^® EXPERT
• Postać: liquid
• siła działania: 38900 mg/kg LD₅₀, oral
• masa cząsteczkowa: 1228 g/mol
• pH: 6-8 (20 °C, 50 g/L, H2O)
• tw: >100 °C
• mp: 98.9 °C
• gęstość: 1.1 g/cm³ at 25 °C
• Zastosowanie: liquid formulation; parenterals; pharmaceutical
• obecność zanieczyszczeń: Aflatoxin free
• temp. przechowywania: 15-25°C
• InChI: 1S/C26H50O10/c1-2-3-4-5-6-7-8-9-10-11-24(30)34-19-18-31-20-22(32-15-12-27)26-25(35-17-14-29)23(21-36-26)33-16-13-28/h22-23,25-29H,2-21H2,1H3
• Klucz InChI: HMFKFHLTUCJZJO-UHFFFAOYSA-N

Opis

Opis ogólny

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.

Zastosowanie

Polysorbate 20 is used to stabilize biomolecule formulations and as solubilizer, emulsifier and wetting agent in small molecule formulation.


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 peroxides.


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

Opakowanie

1.371720100 / 100ml / glass bottle
1.371721000 / 1l / glass bottle

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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Informacja o środkach bezpieczeństwa

• Kod klasy składowania: 10 - Combustible liquids
• Klasa zagrożenia wodnego (WGK): WGK 1
• Temperatura zapłonu (°F): 527.0 °F - Pensky-Martens closed cup
• Temperatura zapłonu (°C): 275 °C - Pensky-Martens closed cup