SoloVPE Application: Polysorbate Analysis

Challenges

• Prepared in water as a stock solution, PS80 is added to the bulk drug substance (BDS). At times, this process can be unreliable — expediently quantifying the volume of surfactant present can be difficult.
• PS80’s viscous, lipophilic nature presents a challenge in accurately weighing and assessing its dissolution in water. 
• Excess amounts of PS80 can be toxic at high concentrations. 
• Current quantification assays can take approximately two days for results.
• Current methods require at least 30- to 50-fold dilutions of PS80 stock solution before measuring, which can result in large errors. 
• Hazardous substances such as methylene chloride or cobalt may be introduced to the process.

The SoloVPE Solution

• Variable pathlength technology allows the user to measure a very wide range of polysorbate 80 and 20. 
• Little to no method development is necessary depending on the concentration of the material. 
• The Slope Spectroscopy® method reduces the time from sample preparation to reproducible results from days to hours, enhancing GMP and GLP practices.
• The System provides highly reproducible results with a variable pathlength allowing an R2 of ≥0.999. 
• The System is an easy inter- and intra-transfer of methods. 
• The instrument is highly sensitive and able to measure from 0.0001% to 25% PS80 stock solution and 0.0001% to 100% PS20

There are no hazardous substances associated with our System so your lab and work space are safe.

See Product