1.37171

TWEEN^® 80

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

• Sinonimo/i: Monooleato di polietilenglicole sorbitano, Monooleato di poliossietilene sorbitano, POE (20) sorbitano monooleato, Polisorbato 80
• Numero CAS: 9005-65-6
• Numero MDL: MFCD00082107
• Codice UNSPSC: 12352207
• Numero indice EU: 500-019-9

Proprietà

• 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
• Stato: liquid
• Potenza: 42200 mg/kg LD₅₀, oral
• PM: 1310 g/mol
• pH: 5-7 (20 °C, 50 g/L)
• P. ebollizione: >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

Descrizione

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

Informazioni sulla sicurezza

• 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