NUVISAN′s solution for Polysorbate Quantification

Polysorbates in Pharmaceutical Drugs

Polysorbates are mixtures of the (partial) esters of sorbitol and its anhydrides which are condensed with approximately 20 moles of ethylene oxide. The most common Polysorbates are oleic (PS80) or lauric acid (PS20) esters. Polysorbates are best known by their brand names: Montanox 80/20 or Tween 80/20 and are commonly used to protect therapeutic proteins from interfacial stress, denaturation and aggregation.

Polysorbate Quantification

Due to the complex chemical structure of polysorbates, chromatographic separation is challenging. Additionally the lack of a UV chromophore in polysorbates prevents the use of conventional HPLC detector systems (e.g. VWD or DAD). Thus, at NUVISAN, quantitation of Polysorbates is routinely performed using Charged Aerosol Detection (CAD), which is a universal detector giving signals independent of the chemical structure through ionization of the analyte.

Various analytical methods are available for the determination of Polysorbates and Polysorbate containing formulations:

HPLC-based Quantitation of Polysorbate 20 and 80

• Charged Aerosol Detector (CAD)
• Evaporative Light Scattering Detector (ELSD)

Identity testing according to EP/USP

• Composition of Fatty Acids (GC-FID)
• FT-IR / FT-NIR Spectrometry

Polysorbate Degradation Products Analysis

• Two-dimensional HPLC (2D-LC)
• High Resolution Mass Spectrometry
• Gas Chromatography/Mass Spectrometry (GC/MS)

Since fatty acids released from Polysorbates have been found to form (sub-) visible particles during some stability studies, we highly recommend accompanying analysis of particulates for comprehensive testing of Polysorbate-containing biological medicinal products. As these reactions are mostly catalyzed by atmospheric oxygen, Container Closure Integrity Testing using non-destructive techniques such as Laser-Headspace and HVLD to confirm primary packaging integrity are also recommended.

NUVISAN supports your projects with tailored method development including practical feasibility evaluation followed by optimization and validation according to GMP / ICH. Our established methods for Polysorbate 20 and 80 can be tailored to customer requirements and are often routinely used during stability studies to determine Polysorbate content. NUVISAN′s standard analytical portfolio for excipients also includes quantitation of L-Methionine, Sodium Lauryl Sulfates, Sodium Citrate, Sorbic Acid, Sorbitol and Glycerol depending of the respective drug formulation.

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