Does Waters have a method for quantitating polysorbate? - WKB229757
Article number: 229757
ENVIRONMENT
- Quantitation
- Polysorbate
ANSWER
Yes, see:
Quantification of Polysorbate Using the ACQUITY UPLC H-Class Bio System with ELS Detection
ELSD Performance on Polysorbate Quantification in Infliximab Drug Products
Comparing ELSD and CAD Performance on Polysorbate Quantification in Infliximab Drug Products
ADDITIONAL INFORMATION
The methods above use the Oasis MAX Online Column, 80Å, 30 µm, 2.1 mm X 20 mm (186002052).
- Polysorbate is trapped at low pH while the therapeutic and other excipients are unretained.
- Polysorbate 80 is a nonionic surfactant.
- Polysorbate 80 is retained onto Oasis MAX by reversed phase only.
- Unretained components are diverted to waste via a switching valve.
- At low pH, biomolecules will carry a positive charge.
- The positive charge on the Oasis MAX particles will repel the positively charged biomolecule off of the packing.
- Large biomolecules are excluded from the pores of the Oasis MAX packing.
- At low pH, biomolecules will carry a positive charge.
- Polysorbate is eluted from the column to the ELSD detector when the switching valve switches back for elution.
The proposed workflow represents a straightforward and efficient method for analyzing polysorbate content in biotherapeutic formulations.
In some cases, the actual gradient table may need to be adjusted in order to properly allow the elution of biomolecules before the polysorbate is able to be eluted away from the biomolecules.
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