Page 18 - Pharmaceutical M5 Biopharma

18  Sponsored Feature

Impurities Investigation of protein aggregation and more

Analysis of Polysorbate 80

Polysorbate 80 (polyoxyethylene sorbitan monooleate) is commonly used as an additive to stabilize recombinant protein in the final formulation.
As reagent, it is a polymeric mixture of a range of carbon numbers and is prone to degradation. Thus, the composition and quantity of polysorbate
80 must be analysed both as raw material and in the final formulation. Shimadzu offers both GC and LCMS solutions to address this need.

Application News: Application News: Application News:
Purity Testing of Polysorbate Analysis of Polysorbate 80 in Analysis of Polysorbate 80 in
80 by GC IgG Aqueous Solution by Online IgG Aqueous Solution by Online
SPE Using Shim-pack MAYI SPE Using Shim-pack MAYI
Column – Quantitative Analysis Column – Quality Analysis

Elemental Impurities Extractables and Leachables

Application News: Application News: Application News:
Analysis of ICH Q3D Guideline Analysis of Styrene Leached Determination of Leachables in
for Elemental Impurities in Drug from Polystyrene Cups Using Orally Inhaled and Nasal Drug
Products Using ICPMS-2030 GCMS coupled with Headspace Products (OINDP) by GC-MS/
(HS) Sampler MS