Pharmaceutical product shelf-life humidity

Blythe (32) made a survey of the stability practices of 40 pharmaceutical companies. He found that a majority used exaggerated conditions of temperature, humidity, and light to test the stability of pharmaceutical products. Correlations of the data obtained with that of shelf-life data differed considerably. 

The amount of scientific information contained in a licensing application may be vast (often exceeding 1000 pages). The pharmaceutical company presents evidence to show that every aspect of production of the medicinal product has been controlled and validated and is of an acceptable quality. The application starts with a description of the discovery chemistry for the new drug. This may be a chemical synthesis or an extraction of an active natural product from a plant or microorganism. Spectroscopic (e.g. NMR, MS, IR) and chromatographic (e.g. HPLC, GC) data are presented to show that the correct compound has been synthesised, and that by-products are identified and their levels controlled. The new chemical entity is then subjected to stability testing under accelerated conditions of heat, humidity, etc. to calculate shelf-life and rates of decomposition. Each decomposition product is identified and any potential toxicity is controlled. 

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