Saturday, October 20, 2018

Residual Solvent Impurities in Pharmaceutical Substances

In the drug products normally water is present. As a result, the most volatile impurity, so far in drug products is water, and a lot of time it does not count as the impurity. It is common in the excipients and drug substances and is utilized in the preparation of dose form too. The content of moisture can be significant as packaged in the dosage form, like there is no equilibration with the environment, under this environment, the moisture brings into the system via excipients may be sufficient to for hydrolysis. In adding, Water from the atmosphere can influence drug products and can often be harmful to their dosage performance or chemical stability. The chemical stability issues linking with water are for the most part caused by hydrolysis, especially carboxylic acid derivatives and other sensitive functionalities. For several drugs, the level of moisture will determine whether a hydrate can generate. In several cases, the formation of the hydrate can cause a loss in crystalline, this, in turn, could get extra chemical instability of the drug.


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