CPMP/ICH// ICH Topic Q1B PRODUCTS. ICH Harmonised Tripartite Guideline . The guideline does not cover the photostability of medicinal products. ICH Q1B C. 1. 2. ICH Q1B Guideline. Photostability Testing of. New Drug Substances and Products. Comments for its Application. This ICH guideline gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.
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The lighting systems used comply with the ICH Q1B Guideline Option 2 and make it possible to perform photostability tests in less than hours.
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ICH Q1B Stability Testing: Photostability Testing of New Drug Substances and Products – ECA Academy
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ICH guideline for photostability testing: aspects and directions for use.
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Stability Testing : Photostability Testing of New Drug Substances and Products
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