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Effects of Impurities in Pharmaceuticals

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We know that the substance that are used in pharmaceutical field must be pure so that they can be used safely. But it is very difficult to obtain an almost pure substance and some traces of impurities are always present. So today we are going to discuss different sources of impurities and some of the effects of impurities in pharmaceuticals.

Sources of impurities

  • Raw materials employed in manufacture.
  • Method or the process used in manufacture.
  • Chemical processes and the plant materials employed in the processes.
  • Storage conditions.
  • Decomposition.

Some Effects of Impurities in Pharmaceuticals

  • Impurities may bring about incompatibility with other substances.
  • Impurities may lower the shelf life of the substances.
  • Impurities may cause difficulties during formulations and use of the substances.
  • Sometimes Impurities changes the physical and chemical properties of the substances.
  • Therapeutic effect can be decreased.
  • Shows toxic effect after a certain period.
  • Injurious when present above certain limits.
  • It may change odour, colour, taste of the substance.

How to Prevent Impurities

There are several ways to prevent impurities in pharmaceuticals. One way is to use the trusted supplier and do ample research before you decide to outsource your medication manufacturing. Another way is to pay special attention to the materials and processes in your lab if you aren’t outsourcing your product. Pharmaceutical impurities can also be controlled by understanding the formation, fate, and purge of the impurities during the manufacturing process. To prevent these impurities many tests such as limit tests are carried out to lower the impurities to make the pharmaceuticals safer.

The percentage of impurities present in a drug substance finally determines the safety of the final drug product, so therefore it is very important and critical to quantify, identify and control the impurities during the drug development process.