Analytical R&D Support

 
 

Analytical Development

Ab Initio has in-house analytical capabilities for product quantification.
Analytical methods can be developed in house or transferred in from another site (i.e. API manufacturer).

  • Full validation packages,

  • Technical transfer and system suitability

  • Early phase method development (total assay and related substances)

  • Seamless transfer from R&D to GMP site for production QC

  • HPLC-PDA/UV

  • HPLC-MS,

  • HPLC-ELSD

  • GC

 

Aerosol Testing

Ab Initio specialises in Aerosol characterisation of orally and nasally inhaled therapeutics

  • MDI, DPI, nebuliser & softmist inhaler characterisation

  • Nasal product characterisation (liquid and powder)

  • Product stability (chemical and physical)

  • Next Generation Impactor (NGI) for DPI and MDI USP <601>

  • NGI (refridgerated) for Nebulisers USP<1601>

  • Anderson Cascade Impactor (ACI)

  • Multistage Liquid Impinger (MSLI) (BP/EP) for high dose formulations

  • Dose Uniformity analysis (MDI, DPI and nasal)

  • Breath Simulation studies (nebuliser)

  • Aerosol droplet size analysis (laser diffraction)


 

Physico-chemical characterisation

Ab Initio can help characterise incoming and processed materials used in your product. Testing includes

  • Drug dissolution (including Apparatus IV for poorly soluble compounds)

  • Thermal and humidity stability control cabinets

  • Accelerated stability and stress testing

  • Product robustness

    • Drop testing and orientation studies

    • Visual inspection and analysis

    • Leakage testing

    • Fibre and particulate analysis

  • Particle size analysis (laser diffraction) -powder and liquid suspensions

  • Differential and thermal gravimetric analysis (DSC/TGA)

  • Modulated DSC

  • Dynamic vapour sorption (DVS)

  • Scanning Electron Microscopy (SEM)

  • Microscopy with chemical analysis (Raman)

  • Atomic force microscopy (AFM)

  • Karl Fischer water analysis

  • Rheometry