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Merck

1.37172

聚山梨酯20

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

别名:

Polyethylene glycol sorbitan monolaurate, Polyoxyethylenesorbitan monolaurate, Polysorbate 20

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化学文摘社编号:
MDL號碼:
分類程式碼代碼:
12161900
酶委員會索引編號:
500-018-3

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生物源

synthetic

品質等級

等級

GMP
Halal
Kosher

agency

ChP
JPE
NF
Ph. Eur.

描述

GMO free
low in endotoxins

產品線

EMPROVE® EXPERT

形狀

liquid

效力

38900 mg/kg LD50, oral

分子量

1228 g/mol

pH值

6-8 (20 °C, 50 g/L, H2O)

bp

>100 °C

mp

98.9 °C

密度

1.1 g/cm3 at 25 °C

應用

liquid formulation
parenterals
pharmaceutical

異物活動

Aflatoxin free

儲存溫度

15-25°C

SMILES 字串

O1C(C(C(C1)OCCO)OCCO)C(OCCO)COCCOC(=O)CCCCCCCCCCC

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 密鑰

HMFKFHLTUCJZJO-UHFFFAOYSA-N

一般說明

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.

應用

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.

包裝

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

法律資訊

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

儲存類別代碼

10 - Combustible liquids

水污染物質分類(WGK)

WGK 1

閃點(°F)

527.0 °F - Pensky-Martens closed cup

閃點(°C)

275 °C - Pensky-Martens closed cup


使用 Emprove® 计划保持符合 GMP 要求

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商品

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.

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

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.

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

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