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Polysorbate 80(II)

Polysorbate 80, also known as Tween 80, is chemically named polyoxyethylene (20) sorbitan monooleate. The relative average molecular weight is 1309.68. Sorbitan is used as the skeleton. The side chains are connected with three oxyethylene chains with hydrophilic characteristics and one aliphatic chain with lipophilic characteristics. Due to the hydrophilicity of ethylene oxide chain segments, polysorbate has a larger HLB value (15.0), it is a non-ionic hydrophilic surfactant with good performance and safety.

Classification:

Pharmaceutical excipients for biologics

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Polysorbate 80(II)

Detailed introduction

1. Product Description

Product Name	English Name	CAS No.	Item No.	Packing specification	Executive standard	CDE Registration Number	FDA Registration Number
Polysorbate 80(II)	Polysorbate 80(II)	9005-65-6	F119-000500	500g/bottle	CP/USP/EP/JP	F20209990843（A）	033606（A）

2. Product advantages

Better appearance: almost colorless appearance, resulting in better quality;

Higher purity: Polysorbate 80(II) uses more than 99% purity oleic acid as raw material;

Lower impurity residues: strict control of product free fatty acid and peroxide residues, strict control of ethylene glycol, diethylene glycol, triethylene glycol impurity residues;

Higher safety: the use of plant-derived fatty acid raw materials, strict control of microorganisms and endotoxins, to meet the injection, eye, inhalation and other high-risk routes of administration needs;

Good packing: the inner packing material is glass bottle, nitrogen protection, more suitable for injection.

3. Product Application

surface active agentPolysorbates (PS) are a family of amphiphilic, nonionic surfactants. High-purity polysorbate 80(II) is the most widely used surfactant in biopharmaceutical formulations to prevent protein denaturation, aggregation, surface adsorption and flocculation, and approximately 70% of monoclonal antibodies are used in these two varieties. Such as: adalimumab, infliximab, etc.

Polysorbate 80(II) is used as a protein stabilizer in most therapeutic protein formulations, mainly because of the following advantages:

1) Good biocompatibility;

2) low toxicity;

3) Effective protein stabilization.

vaccine adjuvantSpan 85 was dispersed in a buffer containing squalene and polysorbate 80, stirred at high speed to a milky state, and then the emulsion was ejected in a microfluidizer to form particles of an O/W emulsion, and the MF59 adjuvant with stability for more than 3 years was obtained by filtration and sterilization. MF59 adjuvant can induce a stronger humoral immune response than aluminum adjuvant. At present, it is widely used in seasonal influenza virus vaccine, new crown vaccine development and major new vaccines.

InjectionHigh-purity polysorbate 80(II) is also widely used as a surfactant and solubilizer for chemical drugs and traditional Chinese medicine injections, such as docetaxel injection, fat-soluble vitamin injection, and Xingnaojing injection.

EmulsifierAs a hydrophilic nonionic surfactant, it is widely used as an emulsifier for stable oil-in-water drug emulsions.

4. Characteristic R & D service

1. National Pharmacopoeia Detection Operation Decomposition Guidance

2. Customized specialty preparation services

Key words:

polysorbate

hydrophilic

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