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Committee for Harmonization Guideline

In order for drug photostability testing to have some predictive validity for the actual conditions under which drugs are produced and handled, the experimental [Pg.84]

The ICH guidelines specify that drugs should be exposed to the following radiation sources during photostability testing  [Pg.85]

Option 1. Artificial daylight fluorescent lamp, or Xenon arc lamp, or metal halide lamp. [Pg.85]

Option 2. Cool white fluorescent lamp and near-UV fluorescent lamp. [Pg.85]

Drug formulations are invariably exposed to EMR that is energetic enough to initiate a variety of photoreactions. [Pg.85]


See other pages where Committee for Harmonization Guideline is mentioned: [Pg.84]   


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