Pharmatek offers state of the art cGMP stability storage and testing capabilities. Standard ICH storage conditions are available as well as a range of other environmental conditions for specialty products or needs. Each cGMP environmental chamber operates independently, with separate temperature and, where applicable, humidity controls. All chambers are continuously monitored by a computerized REES Monitoring System. Temperature and humidity controls are set to industry standards, with deviations outside set point ranges resulting in an immediate alert to Pharmatek staff. Additionally, all storage chambers are supported by full generator back up in case of power failure.

Pharmatek performs release and stability testing for all types of Active Pharmaceutical Ingredient (API) and finished dosage forms including small molecules, generics, peptides, biomolecules and drug-coated medical devices. Appropriate sampling strategies are determined in accordance to client needs and material availability, documented, and executed with the utmost care. Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, in-use stability testing, forced degradation studies and various other stability evaluations. These services are designed and targeted to support clinical trials, IND, NDA and aNDA applications.

Stability Storage Conditions

  • -70°C ± 10°C/Ambient Relative Humidity (RH)
  • -20°C ± 5°C/Ambient RH
  • 5°C ± 3°C/Ambient RH
  • 25°C ± 2°C /Ambient RH
  • 25°C ± 2°C /60% ± 5% RH
  • 30°C ± 2°C /65%± 5% RH
  • 30°C ± 2°C /75%± 5% RH
  • 40°C ± 2°C /75%± 5% RH

The Pharmatek Difference

Stability programs require an ongoing commitment to careful client-focused communications, accurately managed pull schedules and continual review of regulatory requirements. Pharmatek scientists have years of experience performing all types of analytical testing on a wide range of drug substances and drug products. Our extreme attention to detail and the highest level of quality assure our clients that their stability program will be successfully implemented.

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