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Merck
CN

1.37172

SAFC

聚山梨酯20

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

Pharma Manufacturing

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别名:
Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20
CAS号:
MDL编号:
UNSPSC代码:
12352200
EC索引号:
500-018-3

生物来源

synthetic

质量水平

等级

GDP
GMP
Halal
Kosher

Agency

ChP
JPE
NF
Ph. Eur.

描述

GMO free
low in endotoxins

产品线

EMPROVE® EXPERT

形式

liquid

效能

38900 mg/kg LD50, oral

分子量

1228 g/mol

pH值(酸碱度)

6-8 (20 °C, 50 g/L, H2O)

bp

>100 °C

mp

98.9 °C

密度

1.1 g/cm3 at 25 °C

应用

liquid formulation
parenterals
pharmaceutical

异质活性

Aflatoxin free

储存温度

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

InChI key

HMFKFHLTUCJZJO-UHFFFAOYSA-N

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 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.

包装

1.371720100 / 100ml / glass bottle
1.371721000 / 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

储存分类代码

10 - Combustible liquids

WGK

WGK 1

闪点(°F)

527.0 °F - Pensky-Martens closed cup

闪点(°C)

275 °C - Pensky-Martens closed cup


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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

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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