Comply with ICH guidelines on impurities in new drug products

April 2, 2010

The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% ? meeting ICH guideline Q3B(R2)!

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.

You benefit from:

•Sensitivity and linear dynamic range
•Fast results
•Reproducibility
•Ease of use
•21 CFR Part 11 compliance

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 about the Agilent 2100 Bioanalyzer.
Request Agilent’s Protein QC Application CD!

Agilent Technologies, Inc.
Life Sciences and Chemical Analysis Group
5301 Stevens Creek Boulevard
Santa Clara, CA 95051-7201
USA