Drug development requires rigorous stability testing to ensure product efficacy and safety. The EICS Climatic Chamber is positioned as an ideal tool for photodegradation testing according to ICH Q1B, providing a controlled environment to assess the photochemical stability of pharmaceutical products.
1. Purpose of the Study
The main objective is to evaluate the stability of drugs exposed to light, according to the guidelines of ICH Q1B, an international standard that establishes the requirements for photodegradation studies during drug development. This test allows the identification of degradation products and validation of packaging protection.
2. Product Under Evaluation
- Type: Solid pharmaceutical product (film-coated tablets).
- Active substance: photosensitive molecule, susceptible to degradation upon exposure to visible and ultraviolet light.
- Sampling Format: Transparent blister and amber bottle, which are representative of the commercial packaging.
3. Applicable Regulations
ICH Q1B – Photochemical Stability of New Medicinal Products and Substances
This standard requires exposure of samples to:
- UV light (320-400 nm) and visible light.
- Minimum intensity: 1.2 million lux-hour (visible) and 200 W-h/m² (UV).
4. Key Functions of the EICS PRO Climatic Chamber
- Temperature Control: Maintains a stable environment at 25 ± 2 °C, essential for reproducing controlled test conditions.
- Humidity Control: Configurable to 60 ± 5 % RH, ensuring uniform environmental conditions (if applicable).
- Light Source: Incorporates combined UV-A and white visible light lamps, with integrated intensity sensor to monitor lux and W-h/m².
- Recording System: Continuous monitoring with configurable alarms to alert on deviations in light exposure.
- Safety: Includes UV protection for the operator and an automatic locking system during exposure, ensuring safety in the laboratory.
5. Test Procedure
Sample Preparation:
- Packing in representative primary and secondary containers.
- Homogeneous distribution within the chamber to ensure uniform exposure.
Program Setup and Activation:
- Programming of the pre-configured photodegradation cycle according to ICH Q1B.
- Test start with real-time monitoring of light, temperature and humidity parameters by the integrated system.
End of the test:
- The test ends when the set minimum exposure values (1.2 million lux-hours and 200 W-h/m²) are reached.
- Subsequent physico-chemical analysis (e.g. HPLC and spectrophotometry) to detect and quantify drug degradation.
6. Advantages of Using the EICS Climatic Chamber
- Regulatory Compliance: Guarantees photodegradation testing according to ICH Q1B, facilitating certification and regulatory approval.
- High Accuracy and Reproducibility: Automatic control of temperature, humidity and illumination without the need for additional manual settings.
- Resource Optimisation: Reduces costs and test times by enabling continuous monitoring and detailed data generation.
- Intuitive Interface and Connectivity: Enables data export and comprehensive analysis, facilitating decision making in pharmaceutical development.
7. Results and Conclusions
The use of the EICS Climatic Chamber in photodegradation studies allows:
- Identify degradation products in light-sensitive drugs.
- Validate the efficacy of the packaging, checking the protection it offers against light degradation.
- Ensure the stability of the drug under simulated exposure conditions, which contributes to the safety and quality of the final product.
We specify Details
If you are interested in optimising your photodegradation studies and ensuring the quality of your pharmaceuticals, please visit our contact page, leave us your details and we will call you back. Find out how the EICS Climatic Chamber can transform your stability testing and ensure compliance with international regulations.
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