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Inhaler Products

Inhaler products, such as those used to administer medications via the respiratory tract, undergo rigorous quality testing to ensure their effectiveness and safety.

LabAnalysis Life Science is able to provide support, after evaluation, in the analytical control of these products in accordance with the following regulations (EP and USP):

  • Guideline on the pharmaceutical quality of inhalation and nasal products (Doc Ref.: EMEA/CHMP/QWP/49313/2005 Corr)
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations Guidance for Industry

Our main activities are listed below:

  • Stability studies
  • Minimum fill justification
  • Uniformity of dose and fine particle mass across the life of the product at different flows
  • Particle/droplet size distribution
  • Performance of products that have undergone temperature cycles
  • Product performance under different environmental conditions
  • Robustness (drop test, vibration/shock test, patient use simulation)
  • Title, impurities and degradation products
  • Analysis and uniformity of the emitted dose
  • Fine particle mass with use of impactors (NGI, ACI, MSLI)
  • Number of implementations

Sono interessato al servizio Inhaler Products