1.37171

TWEEN^® 80

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

• Sinónimos: Monooleato de POE (20) sorbitano, Monooleato de polietilenglicol sorbitano, Monooleato de polioxietilen sorbitano, Polisorbato 80
• Número de CAS: 9005-65-6
• Número MDL: MFCD00082107
• Código UNSPSC: 12352207
• Número índice de la CE: 500-019-9

Propiedades

• origen biológico: synthetic
• Nivel de calidad: 500
• grado: GMP; Halal; Kosher
• Agency: ChP; JP; NF; Ph. Eur.
• descripción: GMO free; low in endotoxins
• Línea del producto: EMPROVE^® EXPERT
• Formulario: liquid
• potencia: 42200 mg/kg LD₅₀, oral
• mol peso: 1310 g/mol
• pH: 5-7 (20 °C, 50 g/L)
• bp: >100 °C
• densidad: 1.07 g/cm³ at 25 °C
• aplicaciones: liquid formulation; parenterals; pharmaceutical; solubility enhancement
• actividad extraña: Aflatoxin free
• temp. de almacenamiento: 15-25°C
• cadena SMILES: 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+
• Clave InChI: RGPBUVUVZKQNHD-MDZDMXLPSA-N

Descripción

Descripción general

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.

Aplicación

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.

Envase

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

Información legal

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

Información de seguridad

• Código de clase de almacenamiento: 10 - Combustible liquids
• Clase de riesgo para el agua (WGK): WGK 1
• Punto de inflamabilidad (°F): 235.4 °F - closed cup
• Punto de inflamabilidad (°C): > 113 °C - closed cup