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Merck
CN

1.37171

SAFC

吐温80(TWEEN® 80)

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

制药生产

别名:

POE (20)山梨糖醇酐单油酸酯, 聚乙二醇山梨醇酐单油酸酯, 聚山梨酯 80, 聚氧乙烯山梨糖醇酐单油酸酯

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About This Item

CAS号:
MDL编号:
UNSPSC代码:
12352207
EC索引号:
500-019-9

生物来源

synthetic

质量水平

等级

GDP
GMP
Halal
Kosher

Agency

ChP
JP
NF
Ph. Eur.

描述

GMO free
low in endotoxins

产品线

EMPROVE® EXPERT

形式

liquid

效能

42200 mg/kg LD50, oral

分子量

1310 g/mol

pH值(酸碱度)

5-7 (20 °C, 50 g/L)

bp

>100 °C

密度

1.07 g/cm3 at 25 °C

应用

liquid formulation
parenterals
pharmaceutical

异质活性

Aflatoxin free

储存温度

15-25°C

SMILES字符串

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+

InChI key

RGPBUVUVZKQNHD-MDZDMXLPSA-N

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一般描述

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.

应用

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.

包装

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

法律信息

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

储存分类代码

10 - Combustible liquids

WGK

WGK 1

闪点(°F)

235.4 °F - closed cup

闪点(°C)

> 113 °C - closed cup

法规信息

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商品

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

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.

相关内容

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

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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