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Photostability Testing

Photostability Analysis by ICH Q1B Standards

Satisfy ICH Q1B standards with expert photostability testing for your drug product. Photostability studies are performed as part of forced degradation studies, product development, or product investigation and complaint handling. We employ photostability chambers that are temperature-controlled with calibrated UV and visible light sources. These studies are executed based on your internal protocol or protocols drafted by our team. When drafting protocols, our team outlines your product’s exposure needs and the chemical and/or physical testing necessary to fulfill your product’s photostability testing needs.

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Secure Data Accessibility

Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.

The copies are offered in high-resolution and in color, ensuring that your team can review them with clarity and ease. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our quality assurance personnel.

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.