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Photostability - Q1 Scientific
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Photostability

Ensuring the stability of your pharmaceutical products under light exposure is critical for maintaining quality, efficacy, and regulatory compliance. Inadequate photostability testing can lead to degradation, product recalls, and costly delays.

At Q1 Scientific, we provide ICH Q1B compliant photostability testing to help pharmaceutical and life science companies mitigate risks and meet regulatory requirements. Our photostability testing services help generate reliable data on how your products react to light exposure, ensuring they maintain stability throughout their lifecycle.

Photostability Q1 Scientific

Why choose Q1 Scientific for Photostability Testing?

Q1 Scientific

Meet regulatory requirements with confidence

We follow ICH Q1B guidelines, conducting photostability testing on a single batch of material to evaluate how your product responds to light exposure.

Our validated conditions ensure you meet compliance standards and avoid delays in product approval.

Q1 Scientific

Ensure product quality and minimise risk

Our fully-qualified, temperature and humidity controlled photostability chambers simulate real-world exposure, ensuring precise and reliable data.

Whether performing forced degradation or confirmatory studies, we help you proactively safeguard product integrity.

Q1 Scientific

Accurate, reliable and consistent testing

Uniform light exposure: Samples are placed side by side to ensure consistent and repeatable results.

Precise testing duration: All samples undergo light exposure for the exact time required by ICH Q1B standards:

  • Illumination of not less than 1.2 million lux hours (equivalent to 2 to 3 days’ exposure close to a sunny window in the summer).
  • Integrated near UV energy (320 nm to 400 nm: UVA) of not less than 200 watt hours per square meter (equivalent to 1 to 2 days close to a sunny window).

Ongoing monitoring: We use calibrated radiometers and lux meters to monitor light exposure accurately, ensuring the integrity of your data.

Q1 Scientific

In-depth analysis and reporting

Thermal Change Assessment: If specified, we place dark controls (wrapped in aluminium foil) alongside your samples to assess any thermally induced changes.

Detailed Reporting: Our photostability testing generates a detailed graph that confirms light exposure over time, providing you with clear and comprehensive data to support your regulatory submissions.

Photostability testing at Q1 Scientific

Related Resources

Pharmaceutical manufacturers must establish the stability of their drug products towards light.  But what makes a drug molecule or formulation unstable to light, and how can appropriate protection be given?

Find out in this guest post on photostability testing from Dr. Mark Powell, Director of  MP Scientific.

Read More

A complete stability study solution

Stability Storage

Are you running out of stability storage space or struggling with maintaining precise storage conditions? Q1 Scientific is here to solve those problems. We offer ICH and custom temperature and humidity-controlled storage, to keep your samples in optimal conditions.

Our state-of-the-art cGMP stability storage facilities in Belgium, Ireland, and the US provide comprehensive solutions, including –80°C to +50°C storage conditions, thermal cycling, photostability testing, and disaster recovery services.

More Info

Photostability

Ensure product efficacy and safety under light exposure, complying with ICH Q1B guidelines. At Q1 Scientific, we conduct photostability testing on a single batch of material to provide reliable data on how your drug substance or product reacts to light exposure.

Whether performing forced degradation or confirmatory studies, data from our fully qualified, temperature and humidity controlled photostability chambers helps you take proactive steps to ensure product quality and regulatory compliance.

More Info

Thermal Cycling

By recreating the adverse conditions typically encountered during shipment, we provide valuable insights into how your products will react. Our thermal cycling studies are designed to meet ICH Q1A (R2) section 2.1.7 guidelines, ensuring that the storage conditions and study durations are sufficient to cover storage, shipment, and subsequent use. This means you can have confidence that your products will maintain their integrity throughout their journey.

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Ultra Low Freezer Storage

When it comes to storing life-saving vaccines, groundbreaking pharmaceuticals, or delicate biological samples, maintaining their integrity is crucial. Q1 Scientific provides the ideal solution for your ultra-low temperature storage needs, down to -80˚C. At our facilities, we offer all commonly used conditions for biological or vaccine storage:

  • 5°C ± 3°C
  • –20°C ± 5°C
  • –70°C ± 10°C
  • –80°C ± 10°C
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Disaster Recovery

Unexpected events or chamber failures can disrupt your stability studies, leading to critical losses. Protect against unforeseen events with our comprehensive disaster recovery services.

Our disaster recovery procedure ensures the emergency transfer of samples, from individual batches or entire chambers. If one of your stability chambers fails, Q1 Scientific can swiftly take the affected samples, preventing significant interruptions to your stability program while safeguarding your valuable research.

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GDP storage

GDP‑Compliant Pharmaceutical Storage Services in Europe From receipt to release, protect clinical and commercial product integrity with GDP-certified storage designed for regulated supply chains. Q1 Scientific provides secure, validated, temperature-controlled.. More Info

Speak to an expert

Your breakthroughs deserve the right conditions.

Whether you’re looking to discuss your next photostability study or interested in booking a site tour, we’re here to help.

Simply fill out the contact form and our team will get back to you.