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Operating within a Health Canada GMP certified facility, IntelGenx provides clients third-party analytical testing, including method development and validation, release and in-process testing, and ICH stability storage and testing. In our over 1,000 sq. ft. of lab space, we are equipped with cutting-edge technology, enabling a wide range of testing services with short turnaround times at advantageous cost, along with a Level 9 vault for controlled substances storage. The IntelGenx team is driven by the highest commitment to excellence, quality, problem solving, collaboration and customer service.

Testing Services

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SERVICES SUMMARY

  • Method Development or Verification
    • Single or multi-analyte
  • Method Transfer
  • Method Validation
  • Release Testing
  • In-Process Testing
  • Stability Testing and Storage
  • Controlled Substances Storage
 

Capabilities and Expertise

LABORATORY EQUIPMENT HIGHLIGHTS

  • HPLCs
    • Empower 3 (network) operating system
  • Dissolution and Disintegration baths
  • UV/Vis
  • Karl-Fischer apparatus
  • pH meters
  • Viscometers

TESTS PERFORMED

  • Assay and Content Uniformity
  • Dissolution and Disintegration testing
  • Impurities and Degradation Products
  • Water content
  • Physicochemical testing
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Stability Testing

testing

LABORATORY EQUIPMENT HIGHLIGHTS

  • Storage of samples for ICH stability programs
    • Accelerated conditions
      • 40°C / 75% RH
    • Long-term conditions
      • 25°C/65% RH
    • Intermediate conditions
      • 30°C/75% RH
      • Zone IVb
  • Controlled substances storage
  • Stability trend analysis

 

 


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