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ISO/IEC 17025 certified inhalation testing laboratory.

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Product Intro
Microbase Analytical Laboratory

Expert in Inhaled Product Testing Service

We provide customized analytical solutions based on industry guidelines, international standards, pharmacopeias (e.g. Ph. Eur., USP, ChP), and customer requirement. Our team of experts built validated methodologies to accurately acquire data and insight into your device performance.

Regulatory Experience Around the World

Experienced in regulatory compliance testing and submission in international markets. We work closely with our clients to ensure both efficiency and the smoothest path to regulatory approval.

Bringing Your Inhaled Product to Market

We provide integrated solution services to support the commercialization of your inhaled device, ranging from aerosol characterization to drug delivery quantification and submission for regulatory approval.

 

Accreditation

Microbase Analytical Laboratory is accredited under 「ISO/IEC 17025」 for in vitro testing of inhalation products.

 

Inhalation solution and suspension

USP <1601>
EP <2.9.44>

Drug substance delivery rate & total mass of drug substance delivered
  • • Drug Delivery Rate
  • • Total Delivered Dose
Particle Size Distribution
  • • Aerodynamic Mass Median Diameter (AMMD)
  • • Geometric Standard Deviation (GSD)

Nebulizer

ISO 27427
BS EN ISO 27427
BS EN 13544-1

Aerosol Output Rate & Total Aerosol Output
  • • Aerosol Output Rate
  • • Total Aerosol Output
  • • Nebulization Time
  • • Residual Volume
  • • Percentage Volume Nebulized per Minute
Particle Size Distribution
  • • Aerodynamic Mass Median Diameter (AMMD)
  • • Geometric Standard Deviation (GSD)