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