ICH PhotoStability
Storage


At KamTek, we provide ICH-compliant photostability storage and testing to assess the degradation profile of pharmaceutical products under specified light, temperature, and humidity conditions. Our services follow ICH Q1B and ICH Q1A(R2) guidelines to support regulatory submissions for drug development, formulation optimization, and shelf-life determination.

A man holding medicines with a gloved hand

Following ICH Stability Testing Guidelines (ICH Q1B), KamTek’s photostability chambers are precisely controlled and regularly calibrated to meet the minimum light exposure requirements:

ParameterRequirements (per ICH Q1B)
Total Light Exposure≥1.2 million lux-hours
Near-UV Energy≥200 Wh/m²
Temperature MonitoringContinuous
Humidity controlOptional / Customizable

We can tailor exposure protocols to include cool white fluorescent lamps, near-UV lamps (320–400 nm), or custom light profiles based on your formulation and packaging material.

Tests can be performed on unpackaged or packaged products to assess photodegradation under realistic or stress conditions.

What We Offer

  • Photostability Testing (ICH Q1B)
  • Fully validated and monitored storage environments
  • Long-Term, Accelerated, and Intermediate Storage (ICH Q1A)
  • Real-time and forced-degradation protocols

We serve biopharma, research institutions, and CROs requiring GLP-level data integrity, rapid turnaround, and expert handling of light-sensitive or temperature-sensitive compounds.

Applications of KamTek’s Photostability Storage

Our services support a wide range of research, clinical, and commercial applications:

  • Stability testing of new drug substances and drug products
  • Biologics, injectables, and light-sensitive compounds
  • Verification of primary and secondary packaging protection
  • Photodegradation pathway studies for API and excipients

Photo stability storage

Study Design

We consult with your team to define the appropriate ICH Q1A/Q1B protocol, selecting suitable temperature, humidity, and/or light conditions.
Protocols can follow your internal SOPs or be developed by KamTek.

Sample Receipt & Logging

Products are received, inspected, and logged into our secure system with full chain-of-custody documentation.

Controlled Exposure

Samples are placed in validated photostability chambers for light and UV exposure at a controlled temperature and humidity conditions. A positive and negative control are also placed to validate the process.
Each chamber is continuously logged for light, temperature, and humidity, with redundancy and alert systems in place.

Periodic Pulls & Transfers

KamTek can pull and package samples at predefined intervals for analytical testing at your site or ship to third-party labs under controlled conditions.

Final Reporting

At the end of the study or in between, we provide Certificate of ICH Q1B-compliant light exposure,  Environmental logs (temperature/humidity), Sample map and inventory logs. Optional interim reports upon request

Why Choose KamTek

Zero capital requirements

Setting up ICH photostability storage requires significant capital investment in storage devices, monitoring services, documentation, and dedicated personnel. By outsourcing to KamTek, you eliminate these costs while ensuring compliance.

Withdraw Anytime

Our clients have the flexibility to withdraw from the study at any stage, ensuring full control over their R & D efforts.

Regulatory & Licensing Compliance

KamTek meets ICH Q1B, cGMP, and ISO compliance, ensuring that your stability data is globally accepted by regulatory authorities like the FDA, EMA, and other health agencies

Flexible Storage Options

Clients can choose between-Dedicated storage (Reserve an entire chamber for your study), Shared storage (Cost-effective solution for smaller sample quantities).

Disaster Recovery & 24/7 Monitoring

Our facility has oversized backup power generator and stability chambers undergo preventive maintenance with temperature and humidity probe calibrations, and we provide round-the-clock automatic and manual monitoring to prevent disruptions.

End-to-End Solutions

KamTek is your one-stop partner for all associated services related to stability testing, offering secure temperature-controlled storage, shipment logistics, and additional lab testing (microbial and cell culture, assays and other tests) to streamline your workflow.

Frequently Asked Questions

What is photostability testing, and why is it important ?
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What light conditions are used in your chambers ?
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How long does a photostability study take ?
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What kind of reporting will I receive ?
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Which guidelines do you follow for photostability studies ?
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Can you test both packaged and unpackaged products ?
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Do you provide sample pulls and shipping for external analysis ?
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Do you offer both dedicated and shared chamber ?
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Need assistance designing your photostability study?

Our team of experts can help draft protocols and determine test durations based on your product and packaging specifications.