Stability Testing

Stability Testing
Product Description

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlled and monitored with back up chambers at each site. All ICH stability testing sites have 24-hour alarm systems with dedicated on call teams to react to the excursions from storage conditions. Our stability teams provide professionally managed Good Manufacturing Practice (cGMP) ICH stability studies for even the most complex of dosage forms, APIs or product types including orally inhaled and nasal drugproducts (OINDP), biopharmaceuticals, consumer healthcare, medical devices or vaccines. 

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Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile
Categories
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Specifications
  • Details
    GMP Stability Services:

    • cGMP registration stability programs
    • Protocol design and program management
    • Development and validation of stability indicating methods
    • Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, 
    • clinical trial materials, formulated products
    • Tailored reporting (timepoint and final reports)
    • Temperature cycling
    • freeze-thaw study and shipping studies
    • Stability storage outsourcing
    • Forced degradation testing 
    • Real time stability testing
    • Long term stability testing
    • Intermediate stability testing
    • Accelerated stability testing
    • In use stability testing
    • Follow-up stability trials
    • Formulation stability testing
    • Biologics stability studies
    • Specialist expertise for OINDP stability programs
    • Extractables / leachables
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Quality Service; ICH Stability Conditions AvailableWe have an extensive range of ICH pharmaceutical stability storage stability conditions spanning the ICH climatic zones and also bespoke storage capabilities:

    21ºC / 45% RH25ºC / 40% RH
    25ºC / 60% RH
    30ºC / 25% RH
    30ºC / 35% RH
    30ºC / 65% RH
    30ºC / 75% RH
    40ºC / 75% RH
    40ºC / NMT 25%RH
    Cabinets 50 ºC, 57 ºC, 60 ºC
    Storage at 2-8ºC
    ULT storage -20ºC, -40ºC, -80ºC
    ICH Photostability (ICH Q1B Photostability Options 1 & 2)Specialised conditions
    Freeze/thaw temperature cycling tests
  • Supplied from
    Australia; Switzerland; United Kingdom; United States
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Sales Markets
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Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile

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