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Squalene

Squalene, also known as Squalene, is a biodegradable and biocompatible oil, named after it was originally extracted from shark liver oil. It is one of the intermediates in cholesterol biosynthesis and a biosynthetic precursor of all steroids. It exists in almost all animal and plant cells. Because squalene contains six double bonds, it is extremely unstable and easy to oxidize. It will produce a special smell when placed in the air. It is easy to be hydrogenated under the action of nickel, platinum and other metals to form another biologically active substance-squalane. It is a colorless oily liquid at room temperature and insoluble in water. To date, only the extracted purity of squalene of shark origin has been used for the production of vaccines for human use.

Classification:

Pharmaceutical excipients for biologics

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Squalene

Detailed introduction

1. Product Description

Product Name	English Name	CAS No.	Item No.	Packing specification	Executive standard	CDE Registration Number	FDA Registration Number
Squalene	Squalene	111-02-4	F1009-000400	400g/bottle	EP	F20210000392	036346(A)

2. Product advantages

Meet the requirements of regulatory market standards: EP;CDE registration number: F20210000392;DMF registration number: 036346;

Better appearance: colorless appearance, resulting in better quality;

Higher purity: Squalene content up to 99.9%, to ensure the stability of different batches of products;

low peroxide value andAcid value: peroxide value≤ 5.0, acid value ≤ 1.0;

Higher safety: ultrafiltration process, effective removal of bacterial endotoxin; Nanofiltration process, effective removal of virus particles; High purity, ultra-low endotoxin, in line with vaccine injection requirements;

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

3. Product Application

MF59 and most later developed oil-in-water emulsions use squalene. MF59 is currently used in the Fluad trivalent influenza vaccine and the Fluad Quadrivalent quadrivalent influenza vaccine because it improves vaccine response and improves cross-reactivity with multiple influenza virus strains.

AS03 is another squalene oil-based adjuvant that has been used in GSK's H1N1 vaccine (trade name Pandemrix) and H5N1 vaccine (trade name Arepanrix).

Oil-in-water emulsion adjuvants represented by MF59 and AS03 not only enhance the immune response and reduce the dose, but also enhance the vaccine diversity and the affinity of induced antibodies.

4. Characteristic R & D service

1. National Pharmacopoeia Detection Operation Decomposition Guidance

2. Customized specialty preparation services

Key words:

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squalene

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