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Polysorbate 20

Polysorbate 20 is also known as Tween 20. Its chemical name is polyoxyethylene (20) sorbitan monolaurate. Its relative average molecular mass is 1127.48. It uses sorbitan as its backbone. Its side chains are connected with 3 oxyethylene chains with hydrophilic characteristics and 1 aliphatic chain with lipophilic characteristics. Due to the hydrophilicity of ethylene oxide chain segments, polysorbate has a larger HLB value (16.7), it is a non-ionic hydrophilic surfactant with good performance and safety.

Classification:

Pharmaceutical excipients for biologics

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Polysorbate 20

Detailed introduction

1. Product Description

Polysorbate 20, also known as Tween 20, is chemically named polyoxyethylene (20) sorbitan monolaurate. The relative average molecular mass is 1127.48. 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 the ethylene oxide chain segment, polysorbate has a larger HLB value (16.7), it is a non-ionic hydrophilic surfactant with good performance and safety.

Product Name	English Name	CAS No.	Item No.	Packing specification	Executive standard	CDE Registration Number	FDA Registration Number
Polysorbate 20	Polysorbate 20	9005-64-5	F107-000500	500g/bottle	CP/USP/EP/JP	F20209990175（A）	——

2. Product advantages

Meet the needs of different regulatory market standards: CP/USP/EP/JP;

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 20 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 this variety. Such as: adalimumab, infliximab, etc.

Polysorbate 20 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.

InjectionHigh-purity polysorbate 20 is widely used as a surfactant and solubilizer for chemical drugs and traditional Chinese medicine injections, such as docetaxel injection, fat-soluble vitamin injection, Xingnaojing injection, etc.

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

injection

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