ICH Q1B PDF

The ICH Q1B guideline is the harmonised effort to standardise photostability testing on new pharmaceutical drug substances and drug products. All companies developing or manufacturing pharmaceutical drugs, require a robust photostability testing process to ensure product quality and regulatory compliance. Inadequate testing can result in costly delays and lost revenue. Testing is carried out on a single batch of material selected. Under some circumstances these studies should be repeated if certain variations and changes are made to the product e.

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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.

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.

In order to compensate for this reduction, planar sensors with diffusers use what is known as cosine correction. 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.

As a result, the planar sensor needs cosine correction. The second difference relates to the hemispheres of measurement. As Figure 1 shows, a planar sensor can only observe radiation above the sensor surface.

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 actual radiation intensity is measured rather than calculated. 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.

Two spherical sensors that can be freely positioned Figure 3 control the light dosage of UVA at least watt hours per square meter and visible light at least 1. Once the light dosage is achieved, the chamber switches off automatically.

BINDER does not advise using permanently installed sensors, as it can be difficult to fit samples and batches around them. 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 nm and nm. The relative spectral distribution conforms to the F6 standard cool white in accordance with ISO Depending on the type of unit, the length is either mm or 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 nm and nm and between nm and nm. Photostability chambers from BINDER do not use dimmable fluorescent tubes, as this generally leads to changes in the spectral distribution. We live in an aging society.

Medical standards continue to develop and medicine is constantly evolving as scientists carry out research into new Stability testing of new active pharmaceutical ingredients and products in accordance with the ICH Q1A R2 guideline and photostability testing to UVA fluorescent lamps with a spectral distribution of nm to nm and a maximum energy emission of between nm and nm.

A significant proportion of the waves must be within the ranges of nm to nm and nm to nm. The samples should be exposed to visible light VIS for at least 1.

Which light sensors are better: planar or spherical? 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. 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! You might be interested in these posts: February Latest Postings.

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The photostability testing cabinets are characterized by an ideal light, UV, temperature and humidity types L and L distribution and can thus guarantee absolutely reproducible light, UV and climatic conditions. The lighting equipment used complies with the ICH Guideline Q1B Option 2 and enables photostability tests to be carried out in less than hours. One of the most important requirements in photostability tests is the homogeneous irradiation of the specimens. For this reason, all the specimens have to be positioned at the same distance from the light source. The inhomogeneous emission of light by fluorescent lamps is compensated with the help of special light and UV filter systems, thus a homogeneous irradiation of the entire storage area is achieved. For recording of the illumination and UV irradiance this system can be equipped with corresponding light and UV sensors. English Magyar.

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