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Merck

1.37171

SAFC

TWEEN® 80

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

医薬品製造

別名:

POE (20) ソルビタンモノオレエート, ポリエチレングリコールソルビタンモノオレアート, ポリオキシエチレンソルビタンモノオレアート, ポリソルベート80

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About This Item

CAS番号:
MDL番号:
UNSPSCコード:
12352207
EC Index Number:
500-019-9

由来生物

synthetic

品質水準

グレード

GMP
Halal
Kosher

認証

ChP
JP
NF
Ph. Eur.

詳細

GMO free
low in endotoxins

製品種目

EMPROVE® EXPERT

フォーム

liquid

有効性

42200 mg/kg LD50, oral

分子量

1310 g/mol

pH

5-7 (20 °C, 50 g/L)

bp

>100 °C

密度

1.07 g/cm3 at 25 °C

アプリケーション

liquid formulation
parenterals
pharmaceutical

その他の活性

Aflatoxin free

保管温度

15-25°C

SMILES記法

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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詳細

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.

アプリケーション

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

法的情報

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

保管分類コード

10 - Combustible liquids

WGK

WGK 1

引火点(°F)

235.4 °F - closed cup

引火点(℃)

> 113 °C - closed cup


試験成績書(COA)

製品のロット番号・バッチ番号を入力して、試験成績書(COA) を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。

以前この製品を購入いただいたことがある場合

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資料

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.

関連コンテンツ

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.

ライフサイエンス、有機合成、材料科学、クロマトグラフィー、分析など、あらゆる分野の研究に経験のあるメンバーがおります。.

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