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Merck

1.37171

吐温80(TWEEN® 80)

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

同義詞:

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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關於此項目

CAS 編號:
MDL號碼:
分類程式碼代碼:
12352207
酶委員會索引編號:
500-019-9

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生物源

synthetic

品質等級

等級

GMP
Halal
Kosher

agency

ChP
JP
NF
Ph. Eur.

描述

GMO free
low in endotoxins

產品線

EMPROVE® EXPERT

形狀

liquid

效力

42200 mg/kg LD50, oral

分子量

1310 g/mol

雜質

endotoxins, low

pH值

5-7 (20 °C, 50 g/L)

bp

>100 °C

密度

1.07 g/cm3 at 25 °C

應用

liquid formulation
parenterals
pharmaceutical
solubility enhancement

異物活動

Aflatoxin free

儲存溫度

15-25°C

SMILES 字串

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 密鑰

RGPBUVUVZKQNHD-MDZDMXLPSA-N

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本產品
1547969599248.17061
application(s)

liquid formulation
parenterals
pharmaceutical

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

liquid formulation
ophthalmics
pharma/biopharma processes
pharmaceutical
semi-solid formulation
solid formulation
solubility enhancement

agency

ChP, NF, JP, Ph. Eur.

agency

-

agency

USP/NF, tested according to Ph. Eur.

agency

JP, NF, Ph. Eur.

form

liquid

form

-

form

liquid

form

viscous liquid

density

1.07 g/cm3 at 25 °C

density

-

density

1.064 g/mL at 25 °C (lit.)

density

1.07 g/cm3 at 25 °C

product line

EMPROVE® EXPERT

product line

-

product line

-

product line

EMPROVE® ESSENTIAL

biological source

synthetic

biological source

-

biological source

-

biological source

-

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 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.

包裝

1371710100 / 100ml / glass bottle
1371711000 / 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
TWEEN is a registered trademark of Croda International PLC

儲存類別代碼

10 - Combustible liquids

水污染物質分類(WGK)

WGK 1

閃點(°F)

235.4 °F - closed cup

閃點(°C)

> 113 °C - closed cup


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文章

與成人相比,兒童用藥面臨獨特的配方挑戰。在設計藥品時,請考慮兒童的發育生理和年齡特徵。品質問題會嚴重影響病患安全。因此,輔料品質、供應商選擇和供應鏈安全是至關重要的,特別是對於兒科配方。

本文概述了蛋白質長期穩定性的關鍵因素,以及不同的穩定劑如何保護蛋白質免受機械和熱應力的影響。

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.

相關內容

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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