Is stability testing available?

Axcentria offers stability storage and testing requirements. We offer ICH  (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and customized storage conditions. Our stability chambers have monitoring with redundant systems, backup power and comprehensive disaster recovery plans. 

What testing do you perform on products?

All products manufactured by Axcentria are tested according to specifications for:

  • Appearance
  • Physical properties
  • Potency of ingredients
  • Impurities

Microbiological tests are required to ensure that our quality control of the product is maintained throughout the manufacturing and packaging processes without any microbial cross contamination. The FDA has pre-established total microbial contamination limits and identification of specific organisms to reduce consumer risk.

Can Axcentria develop analytic methodology for processes and testing?

Axcentria offers fully integrated analytical services that include method development, method validation and testing using the latest analytical technologies. Our cGMP analytical laboratories have efficient and flexible quality systems aligned with our project management, formulation development and manufacturing operations.

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