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ISO/IEC 17025 certified inhalation testing laboratory.
Analytic and Calibration Lab
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Product Intro
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 Analytic Lab is a fully ISO/IEC 17025 laboratory for performance testing of inhaled product.
Inhalation solution and suspension
USP <1601>
EP <2.9.44>
Drug substance delivery rate and total mass of drug substance delivered
- Drug substance delivery rate
- Total mass of drug substance delivered
Aerodynamic assessment of nebulized aerosols
- MMAD
- GSD
Nebulizer
ISO 27427
EN ISO 27427
EN 13544-1
Aerosol output rate and aerosol output
- Aerosol output rate
- Aerosol output
- Nebulization time
- Residual volume
- Percentage of fill volume emitted per min
Particle sizing
- MMAD
- GSD
