Characterization & Development Studies
Analytical characterization builds the understanding needed to make sound formulation, process, stability, and development decisions.
Teleios supports drug substance and drug product characterization throughout development.
What We Can Support
- Drug substance characterization
- Drug product characterization
- Assay and impurity profiling
- Formulation related investigations
- Excipient related studies
- Forced degradation
- Stability support
- Residual solvent analysis
- Development investigations
Typical Analytical Questions
- How does the product change under stress or storage?
- What degradation pathways are present?
- Are formulation components affecting product quality?
- What analytical attributes should be monitored during development?
Analytical Approach
Studies are scoped to the development stage and the decision being supported, using chromatographic, mass spectrometric, and elemental techniques selected for the product and matrix.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
- ICH Q1B — Photostability Testing
- ICH Q2(R2) — Validation of Analytical Procedures
- ICH Q3A and Q3B — Impurities
- ICH Q3C — Residual Solvents
- Applicable USP requirements and product specific expectations
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.