We have an unknown peak, impurity, or degradant
Identify unexpected chromatographic peaks, process impurities, degradation products, and drug-product reaction products using mass spectrometry and orthogonal structural evidence.
Pharmaceutical foreign-particulate, unknown-material, and impurity identification
Investigate an unexpected chromatographic peak, foreign particulate, residue, deposit, discoloration, or unknown material using microscopy, spectroscopy, chromatography, mass spectrometry, diffraction, and elemental analysis. Triclinic connects material identity with comparison samples and process context to support pharmaceutical quality, manufacturing, supplier, packaging, and root-cause decisions.
Start with the problem you need to solve
Choose the path that best matches the observation or decision. Triclinic will then select the techniques, controls, comparisons, and evidence level appropriate to the sample.
We need to isolate an impurity for definitive identification
Use preparative liquid chromatography to isolate or enrich an unknown peak for LC-MS, NMR, or other confirmatory structural analysis.
We found an unknown particle, residue, or material
Identify foreign particulates, fibers, films, deposits, stains, residues, and mixed materials using microscopy, spectroscopy, diffraction, and elemental evidence.
We need to determine the source or root cause
Connect material identity, morphology, source comparisons, process history, and batch context to deviations, out-of-specification findings, or manufacturing failures.
We have a process contamination or material-failure problem
Compare suspect process samples with virgin materials, acceptable lots, tank fluids, cleaning agents, equipment-contact materials, and other source candidates.
We need to quantify an elemental impurity or contaminant
Measure bulk or localized elemental signals and interpret metallic, mineral, catalyst, residue, and source-related findings.
We suspect packaging or contact-material involvement
Investigate extractable- or leachable-like findings associated with packaging, devices, components, process-contact materials, and product-contact surfaces.
We need to compare an authentic and suspect product
Compare dosage forms, ingredients, particles, formulation signatures, seals, labels, and packaging to evaluate authenticity or suspected counterfeiting.
Working with a trace-level or very small sample? Low abundance is a scoping condition across these services. Review trace-level analysis considerations, including sampling, isolation, contamination control, matrix interference, and detection limits.
What happens after you select a path
Triclinic begins with the observation, available material, sample history, comparison samples, prior data, and the decision the evidence must support. The analytical plan then distinguishes identification from source attribution, quantitation, structural confirmation, and root-cause assessment.
Common Questions
What should be sent for a contaminant or impurity investigation?
Send the unknown material if available, retained acceptable lots, suspect lots, process materials, packaging, cleaning agents, suspected sources, photos, prior data, and chain-of-custody or sampling context.
Can Triclinic identify mixed or microscopic materials?
Often yes, but the conclusion may require microscopy, Raman, FTIR, SEM/EDX, chromatography, MS, elemental analysis, and reference comparisons rather than one technique.
Can this support quality or manufacturing investigations?
Yes, when the scope includes relevant comparison materials, material history, sampling context, and documentation appropriate to the investigation.
What if the unknown is only a trace-level signal?
Trace-level work may require targeted preparation, enrichment, high-sensitivity methods, or orthogonal follow-up to separate real signals from matrix interference and artifacts.
How much material is needed for an investigation?
The amount depends on particle size, concentration, sample matrix, homogeneity, and the techniques required. Small visible particles may be analyzed individually, while trace-level or heterogeneous samples may require more material, enrichment, separation, or replicate preparation.
Investigate a contaminant or impurity
Send the material, current data, suspected sources, comparison samples, project objective, quality requirements, and timeline.
