Titanium dioxide (TiO2) has been a critical excipient in pharmaceuticals for decades, offering exceptional opacity, whiteness, and stability. However, evolving regulatory demands are driving the industry to explore alternatives. Resolian provides advanced analytical and characterization support to guide this transition while ensuring product quality and compliance.
How We Can Help
We can apply a holistic approach to evaluate TiO2 alternatives, combining decades of expertise in analytical chemistry and physical characterization techniques.
Stability and Compatibility
Understanding the stability of TiO2 replacements is critical for maintaining product performance over its shelf life. We analyse how alternatives interact with active ingredients and excipients evaluating:
- Long-term and accelerated stability, monitoring degradation products and interactions through HPLC/UPLC and mass spectrometry.
- Thermal stability and moisture sensitivity under storage and processing conditions with DSC, TGA, and DVS.
- Dissolution studies to assess the impact of TiO2 alternatives on drug release profiles and bioavailability.
Material Behaviour and Functionality
The physical characteristics of TiO2 alternatives directly impact their efficacy as opacifiers or colourants. We assess:
- Particle size, distribution, and morphology using laser diffraction, dynamic image analysis, and SEM.
- Surface properties and reactivity through BET and iGC-SEA for adhesion and coating optimisation.
- Crystallinity and structural and chemical changes via XRD and FTIR.
Appearance and Uniformity
Maintaining visual consistency and achieving the required opacity are challenges for TiO2 alternatives.
We examine material uniformity and appearance using visual inspection and light microscopy.
Regulatory and Safety Compliance
Ensuring that alternatives meet stringent regulatory requirements is essential.
We also conduct risk assessments for elemental impurities and nitrosamines and perform extractables & leachables testing to support regulatory submissions.
