Safe Stability Solutions
Aug 04 2008
Drug products are produced using bulk pharmaceutical chemicals. Manufacturers of their inactive ingredients have to comply with GMP
regulations, which become relevant where a substance enters a biological or chemical synthesis or a series of processing steps.
The regulations require that all drugs be manufactured, processed, packed and held in accordance with current good manufacturing practice. During the development phase of a medicinal product, stability of the chemical constituents has to be analysed because undetected changes in raw materials specifications may affect their stability.
Vindon stores stability samples in containers that approximate to the market container. As recommended by the FDA, they also store additional samples under stressful conditions such as high temperature, light, humidity or freezing. In a world of costly pharmaceuticals, Vindon leave nothing to chance.
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