ICH Q1B Photostability tests seen in a whole new light

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The 1996 guideline CPMP/ICH/279/95 Q1B describes the process for carrying out photostability tests on new active substances and medicinal products. 

It stipulates the following: 

  1.  Cool white fluorescent lamps with an output similar to that stipulated in ISO 10977 (1993). 
  2. UVA fluorescent lamps with a spectral distribution of 320 nm to 400 nm and a maximum energy emission of between 350 nm and 370 nm. A significant proportion of the waves must be within the ranges of 320 nm to 360 nm and 360 nm to 400 nm. 
  3. The samples should be exposed to visible light (VIS) for at least 1.2 million lux hours and to UVA for at least 200 watt hours per square meter. 

The specifications listed above are well known. Less familiar, however, are the intricacies that need to be taken into account when implementing the ICH Q1B guideline in photostability chambers featuring ICH-compliant irradiation facilities.  

This blog article introduces two light photometry methods for photostability tests that comply with ICH Q1B, discusses ICH-compliant light sources, and considers the key pros and cons.

Which light sensors are better: planar or spherical? For us, there’s no competition  

Two types of light sensors are available for ICH Q1B photostability tests – detectors with a flat sensor surface (planar sensors) and detectors with a spherical sensor surface (spherical sensors). There are two major differences between them – in one case, the sensor calculates the intensity of the radiation, whereas the other measures the actual radiation intensity. 

Lambert’s cosine law states that radiation intensity decreases as angles become more oblique. In order to compensate for this reduction, planar sensors with diffusers use what is known as cosine correction. This means that only a small proportion of the radiation that hits the sensor surface is actually measured – the radiation that hits at a 90° angle. For all other angles of incidence (see Figure 1), the radiation intensity is calculated using a mathematical equation. 

This is why BINDER does not recommend using planar sensors with diffusers to test the photostability of new active substances and medicinal products. The same applies to planar sensors without diffusers, as they record even less of the actual radiation intensity. 

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Figure 1: Lambert’s cosine law states that radiation intensity decreases as angles become more oblique.  As a result, the planar sensor needs cosine correction.  The image shows the angle of incidence on the planar sensor surface with the percentage of incoming radiation in each case, compared to an angle of incidence of 90° (100%). 

The second difference relates to the hemispheres of measurement. As Figure 1 shows, a planar sensor can only observe radiation above the sensor surface. It cannot record radiation that has an angle of incidence of either 0° or 180°. In addition, it cannot record any radiation from below. 

In complete contrast to this, the spherical sensor measures the actual radiation intensity from all directions, meaning that it even records scattered radiation (Figure 2). The radiation always hits the sensor at a 90° angle, which removes the need for cosine correction. The actual radiation intensity is measured rather than calculated. 

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Figure 2: A spherical sensor makes it possible to measure the radiation intensity from all directions. 

As the spherical sensor is the only sensor type that actually measures radiation intensity and records scattered radiation, we have been using exclusively spherical, freely positionable sensors in our KBF LQC photostability chambers for years now. 

LQC stands for Light Quantum Control™ and is our patented light photometry method for photostability tests. Two spherical sensors that can be freely positioned (Figure 3) control the light dosage of UVA (at least 200 watt hours per square meter) and visible light (at least 1.2 million lux hours). Once the light dosage is achieved, the chamber switches off automatically. 

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Figure 3: Two golf ball-sized spherical sensors can be freely positioned in the KBF LQC chamber to measure UVA and visible light (VIS).

BINDER does not advise using permanently installed sensors, as it can be difficult to fit samples and batches around them.

ICH-compliant light sources

The VIS element is generated using bright white T8 fluorescent tubes in a rod shape with a diameter of 26 mm. The emission range is between 400 nm and 700 nm. The relative spectral distribution conforms to the F6 standard (cool white) in accordance with ISO 10977. Depending on the type of unit, the length is either 600 mm or 900 mm. 

The UVA element is generated using T8 fluorescent tubes in a rod shape with a diameter of 26 mm. The emission ranges are between 320 nm and 400 nm and between 400 nm and 700 nm. Depending on the type of unit, the length is either 600 mm or 900 mm. 

The fluorescent tubes with a UVA element (BINDER Q1B Synergy Light) switch off independently of the bright white fluorescent tubes once the target value stipulated by guideline CPMP/ICH/279/95 (Q1B) has been reached.  

Photostability chambers from BINDER do not use dimmable fluorescent tubes, as this generally leads to changes in the spectral distribution. 

Buyer’s Guide for constant climate chambers in the pharmaceutical industry

A prerequisite for successful long-term stability tests according to ICH guidelines, or real-time shelf-life tests over months and years, is smooth continuous operation of the constant climate chamber.

What technical solutions are currently available to ensure reliable continuous operation?
Which factors should you pay particular attention to and what are the advantages
and disadvantages?

Here are the 6 most important points to watch out for!

 

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Buyer’s Guide for constant climate chambers in the pharmaceutical industry


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