A Complete Guide to Impurity Studies in Drug Development.

Ensuring Pharmaceutical Product Safety. A detailed exploration of impurity studies, highlighting their significance in safeguarding patient well-being and maintaining product quality.

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In the realm of pharmaceutical development, impurity studies play a pivotal role in ensuring the safety and efficacy of drugs. According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines Q3A and Q3B, impurities in drug substances are defined as "substances in the API that are not the API itself" and in drug products as "substances in the product that are not the API itself or the excipients used to manufacture it."

Key highlights include:

  • Understanding the different types and sources of impurities in pharmaceuticals.
  • Exploring regulatory guidelines and compliance standards for impurity control.
  • Proactive measures and strategies for early detection and mitigation of impurities.

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