Automatic and reliable detection and quantification of low concentrated protein impurities down to 0.05% and below with the Agilent 2100 Bioanalyzer!
The Agilent 2100 Bioanalyzer together with the Agilent High Sensitivity Protein 250 Kit allows you to reliably detect and quantify low concentrated impurities next to massive main components – down to 0.05% and below. This meets the ICH guideline Q3B(R2): Impurities in New Drug Products! Reporting threshold 0.05% for a maximum daily dose >1g.
The Agilent 2100 Bioanalyzer provides:
The High Sensitivity Protein 250 kit provides the first microfluidic assay for protein detection in the low picogram range. Therefore, the kit is suited excellent to solve typical protein QA/QC questions and to comply with ICH and FDA guidelines – in the Bioanalyzer-like, fast and reproducible way.
Learn more!Receive a free Protein QC application CD!
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Agilent Technologies, Inc.
Life Sciences and Chemical Analysis Group
5301 Stevens Creek Boulevard
Santa Clara, CA 95051-7201
USA
Diving Deep into Carrier-Based Formulation and Process Optimization
December 23rd 2024Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations