Unknown Impurity Identification & Characterization
Unexpected peaks, degradants, contaminants, and process related impurities often require more than routine chromatographic testing.
Teleios applies high resolution accurate mass analysis and complementary analytical approaches to support identification and structural investigation of unknown compounds.
What We Can Support
- Unknown peak investigation
- Impurity profiling
- Degradation product characterization
- Accurate mass determination
- Molecular formula assessment
- Structural investigation
- Targeted follow up analysis
- Comparison of process or formulation related impurities
Typical Analytical Questions
- What is the unknown peak?
- Is the compound related to the active ingredient, excipient, process, packaging, or degradation?
- Does the impurity require further identification or qualification?
- Is the impurity increasing during stability or manufacturing?
Analytical Approach
Investigations combine high resolution accurate mass analysis, fragmentation data, and orthogonal separations. Findings are evaluated against the drug substance, formulation, process, and packaging to support a defensible structural assignment.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- ICH Q3A(R2) — Impurities in New Drug Substances
- ICH Q3B(R2) — Impurities in New Drug Products
- ICH Q3C — Residual Solvents when applicable
- ICH M7(R2) for impurities with potential mutagenic concern
- Applicable regulatory reporting, identification, and qualification thresholds
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.