Analysis of Surfactants Quantification and Characterisation by Solid Phase Extraction (SPE) (CAT#: STEM-B-0371-CJ)

Introduction

Surfactants stabilize biomolecules against interfacial stress and/or prevent adsorption. Polysorbate 20, polysorbate 80 and poloxamer 189 are surfactants for parenteral application in biopharmaceutical products. Besides their benefits, it is common knowledge that surfactants, such as polysorbates, are prone to degradation by hydrolysis and oxidation. While such degradation can directly affect the function of the surfactant, it could also lead to the formation of insoluble fatty acid-related particles over time - a potential issue for the safety and efficacy of a biopharmaceutical drug product.

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Principle Applications Procedure Materials Notes Related Products

Principle

Solid phase extraction employs the same basic principles as chromatography. SPE makes use of the same HPLC column solid phase packing materials in a single-use container such as plastic tubular cartridges , 96-well plates, or pipette tips. Like HPLC columns, there are many stationary phase options to choose from, such as reversed phase, ion exchange, normal phase, and mixed mode phases. Unlike HPLC, SPE is typically performed as a low resolution and very low-pressure method designed to prepare samples by removing interfering substances or concentrating a sample.

Applications

Biopharmaceutica

Procedure

1. Sample pre-treatment.
2. Column conditioning.
3. Column re-equilibration after column conditioning.
4. Sample application.
5. Solvent wash to remove interferences.
6. Elute compounds of interest.

Materials

• Sample: Surfactants (such as: integral part of biopharmaceutical formulations), polysorbate 20 (PS20), polysorbate 80 (PS82), Buffer excipients (such as: amino acids or saccharides), Small molecule APIs
• Equipment: Solid Phase Extraction Equipment

Notes

• The quality requirements for pharmaceutical grade polysorbate 20 and 80 are specified in the different pharmacopoeias. For polysorbate 80, the Chinese Pharmacopoeia describes the strictest regulations for the fatty acid composition and requests an all-oleate polysorbate (≥ 98%), whereas the European and US pharmacopoeias specify a purity of ≥ 58% for oleic acid.
• SPE makes use of a solid phase material (there are many to choose from) that functions to retain the interfering substances, while solvents elute the sample, which is collected and analyzed.

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