Impurity Qualification of New Drug Substance / Drug Product: Safety Studies

Impurity is any component of the new drug substance/product that is not the drug substance or an excipient in the drug product. Impurities may arise from a variety of sources. Manufacturing impurities, leachable impurities, and degradation impurities are the most common. Qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified in the regulatory documents.

  • Manufacturing impurities can come from raw materials, active ingredients, excipients, process impurities and packaging impurities.
  • Leachable impurities are compounds that migrate into the formulation from the label, container components, or coatings of the container and closure system as a result of direct contact with the formulation. These impurities would be formed during normal storage and handling conditions. Certain types of storage or treatment conditions may also produce leachable more readily, including sterilization procedures.
  • Degradation impurities are formed from the breakdown of the drug substance or product, possibly due to storage conditions, interaction of ingredients from the container, label or closing systems, or treatment of the material.

It is essential that proper analyses be conducted for impurities. Knowledge gained from these analyses can be used to guide formulation development and improve manufacturing and packaging processes. Degradation products if detected in significant amounts should be identified, tested for, and monitored against appropriately established acceptance criteria, according to ICH Harmonized Guideline.

Expertise Available:
  • Adgyl Lifesciences has 30+ years of experience in conducting safety studies and have designed and reported more than 100 GLP impurity qualification studies for various class of drug substances and products.
  • Expertise in custom designing qualification studies for unusual impurities that may occur in API and Drug product.
  • Intimate knowledge in qualifying impurities alone, API with impurity and impurity with Drug product during storage.
  • Testing strategies devised based on therapeutic indication, impurity levels and limitation of impurity supply.
  • Our data/reports on impurity qualification submitted to various regulatory agencies in US, Europe and other regulated countries.