Your project: Photostability Testing
Procedure: Guideline 3AQ18A,
previous title: ICH Q1B, „Photostability Testing for New Substances and Products“, CPMP/ICH/279/95,
Legislative basis: Directive 75/318/EEC
Our offer: Performing photostability testing of your samples as your contract laboratory; documentation, and re-shipment of exposed samples;
Optional: Analytical work on exposed samples
Methodology: „confirmatory“:
10-12 hours illumination by means of Xenon-light, precisely meeting “not less than 1,2 mio lux hours” and “not less than 200 Watt hours/m2” integrated near ultraviolet UV energy (“option 1”);
same minimum requirments, but alternate “option 2” by means of “cool white fluorescent lamp” and “near UV lamps”„accelerated“:
light challenge exceeding the minimum requirements significantly with regard to time and to the UV compartment of the light
Our competence: Broad expertise in photostability testing of starting materials, bulk products, finished and finally packed products, and packaging components;

Availability of Xenon-light-cabinets with “cool air” ventilation and also with water-cooled stainless steel bottom;

Availability of cabinets with “cool white fluorescent” lamps and “near UV lamps” and free choice of temperature and humidity;

Documented qualification and calibration of these devices;

Calibration by chemical actinometry;

Optional chemical actinometry during your test;

Preparation of self-explanatory reports with comprehensive description of the method and technique applied strictly following ICH Q1B;

On request: Investigation of appearance, content, and purity of exposed samples, e.g. by HPLC, TLC, GC

We perform the illumination at short notice practically immediately after receipt of your samples;

Re-shipment of exposed samples can be arranged within 48 hours after receipt.

Your dialogue partner: Natalie Nicola, Biologist
Tel: 0049 (0)7251 72484-26
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