Stability Studies

Stability Studies

Drug stability research is an important part of drug product development and life cycle, especially to support development and IND/NDA submission activities. They allow the stability of the active drug component (API) or the stability of the drug product to be evaluated under the influence of various environmental factors such as temperature, humidity and light. Data from these studies enable the recommended storage conditions, retest intervals, and shelf life to be determined. In conclusion, monitoring the impact of environmental conditions on the quality of medicines, substances, medical devices and raw materials is important to determine whether they are suitable for consumer use or for use in production.

Below is a list of our Stability Services (including but not limit following):

  • CGMP registers the stability program.
  • Protocol design and program management.
  • Development and verification of stability indication methods.
  • Stability test of raw materials, clinical trial materials and prepared products.
  • Tailor-made reports (point-in-time and final reports).
  • Study on temperature cycle, freeze-thaw and shipping.
  • Stabilization of emergency and disaster recovery stocks.
  • Forced degradation test.
  • Real-time stability test.
  • Accelerated stability test.
  • Formulation stability test.
  • Study on the stability of biological agents.
  • Expertise in OINDP stabilization projects.
  • Extractable/leachable

Our Advantages

  • Enough storage space to satisfy your needs
  • Cold-chain management and secure-monitored shipping
  • Comprehensive services for your biopharmaceutical and chemical drugs
  • Capable of offering alternate temperature and humidity conditions to meet specific requirements
  • Development and validation of stability indicating methods
  • Interim reports for every testing period

Our analytical laboratories provides the development and validation of stability indication methods through state-of-the-art technology to identify and quantify degradation products. Conventional time-point tests include conventional tests and routine tests such as impurity analysis, dissolution, moisture, hardness, fragility and disintegration. BOC Sciences scientists have expertise in OINDP testing as part of a stability program that includes measuring the size of particles or droplets and providing key data for understanding the size distribution of delivered preparations and the release of drugs in the equipment. With unparalleled know-how in extractable and leachate research, we can ensure that complete product and packaging systems show adequate stability and protection in your product’s related life cycle.

References

  1. Kundur, P., Balu, N. J., & Lauby, M. G. (1994). Power system stability and control (Vol. 7). New York: McGraw-hill.

If you have questions about our services at any time, just give us a call or send us an email at . We will do all we can to meet your needs.

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