Safety profiles biological data

For biological products (the chemical) excipients are often overlooked. They, too, may have effects or side effects and can leave residues in animals that end up in human food. Their choice for a development product must be considered carefully. Either one uses ingredients with a well established quality and safety profile or one must face the fact that a variety of analytical and safety data have to be established for these excipients. Safety studies for new excipients may cost more than the safety assessment of the biological product itself. 

SAFETY PROFILE Moderately toxic by ingestion and subcutaneous routes. Questionable carcinogen with experimental mmorigenic data. Mutation data reported. When heated to decomposition it emits very toxic fumes of NOx and HCl. Used as a colorant in textiles, paper, leather, inks, wood, and biological stains. 

The chromatographic profile should feature the fundamental attributions of sameness and differences of the constituents of the investigated extract and define their quality in order to get reproducible biological data in terms of safety and efficacy. The analytical methods should be so precise that different batches of the extract in question will have the same efficacy. As described above, it has now become routine to define a ginkgo extract in terms of the content of the two groups, the flavonoid glycosides and... 

Qualification of impurities—this section addresses the evaluation data for assessing the biological safety of an individual impurity or a given impurity profile at the levels specified. 

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