Stability and QC Services – Delivering Assurance
Customised stability programs and protocol creation.
Stability program management including timepoint testing and reporting.
Sample storage using ICH conditions.
Stability consulting – to match client needs with regulatory requirements.
Testing services include:
- Verification of API identity
- Viscosity
- pH
- Assay and related substances
- Homogeneity
- Dose content uniformity
- Osmolality
- Surface tension
- Water content by KF
- Water activity
- Soluble fraction of a suspension
- Particle Size Distribution (Laser Diffraction)
- Weight change
- In-Use Stability Studies
- Temperature cycling studies
- Container closure assessments (drop size, dimensions, plastic materials of construction)
- Risk assessments (i.e., Residual solvents, Elemental Impurities, Nitrosamines)
Applications include:
- Pharmaceutical, Biotech
- Academia, Universities, Institutes
- Veterinary products
- Cosmeceuticals. Dermaceuticals
- Complimentary medicines
- Industrial