Pharmaceutical Sciences: Stability Studies | SRI International

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Pharmaceutical Sciences: Stability Studies

SRI Biosciences conducts stability studies of pharmaceuticals to identify impurities and degradation. We offer stability storage and testing that adheres to International Conference on Harmonization (ICH) guidelines. Standard storage conditions include frozen (ultracold and -20°C), refrigerated (5°C), ambient (25°C/60% relative humidity), intermediate (30°C/65% relative humidity), and accelerated (40°C/75% relative humidity). Custom storage conditions and specialized climatic zone considerations can also be accommodated.

Stability studies include

  • Long-term drug substance and drug product stability studies of pharmaceuticals to support ongoing clinical trials

  • Short-term stability studies for the evaluation of candidate formulations

  • Photostability studies

  • Temperature cycle studies

To identify, track, and quantify impurities and degradation products, SRI's analytical and synthetic chemists offer these services:

  • Forced degradation studies to develop sensitive and specific analytical methods

  • Structure elucidation techniques

  • The synthesis of reference standards for the active ingredient and degradation products to support ongoing stability assessments

To ensure the quality and security of drug substances and drug products, the stability storage services program features

  • Storage units with validated conditions of temperature, humidity, and light (visible and ultraviolet)

  • A validated computerized system for the continuous monitoring of temperature, humidity, and light, with cumulative reports

  • Emergency power backup for chambers and computer monitoring systems

  • Local audible alarms, an automatic notification system, and 24/7 on-site security personnel with protocols for notifying facility engineers and technical staff

  • A double-lock system to access chambers

Projects

Partnering to Advance Therapy for Radiation Exposure

Partnering to Advance Therapy for Radiation Exposure