Tackling the Challenge of Impurities
Impurities can be a big problem if not properly identified and documented. Recent events have brought impurities to the top of the regulatory oversight.
Depending on your role, USP offers both compendial Reference Standards (RS) and an entire catalog of Pharmaceutical Analytical Impurities (PAIs) – well-characterized materials that are not related to a compendial use requirement.
For R&D and Method Development: Identify contaminants early! Use well-characterized materials to characterize relevant impurities.
- Materials that help accelerate your product submissions:
- Impurity Reference Standards
- Nitrosamine Reference Standards
- Pharmaceutical Analytical Impurities
For QC/QA: Reduce introducing risk into your processes! Only USP standards, used with USP documentary standards, ensure conclusive results.
- Obtain conclusive results when using:
- USP-NF/PF Online + USP Reference Standards
- Application Notes
- Impurities for Cleaning method validation and Stability Studies
- Impurities to support pharmaceutical product investigations
Helpful links:
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