Material science in pharmaceuticals requires the expertise to evaluate each API using a variety of techniques. We characterize your material completely, and we interpret what the data mean for your development.
At PCL Research & Manufacturing we support the characterization of your APIs and finished products using Polarizing Light Microscopy, Scanning Electron Microscopy, Differential Scanning Calorimetry, Thermogravimetric Analysis, particle size distribution by light scattering and X-Ray Powder Diffraction — and our capabilities go well beyond that list.
Solid-state questions rarely have single-technique answers. A thermal event in a DSC trace could be a polymorphic transition, a desolvation, a melt or a decomposition, and only the combination with thermogravimetry, diffraction and microscopy settles which. A laboratory with one instrument gives you a measurement; a laboratory with the full set gives you an interpretation.
That is the distinction we work to. The data package is assembled so that each conclusion is supported by more than one independent observation.
Characterization is scoped to the question — batch comparison, investigation of a deviation, full material qualification or support for a regulatory submission.
X-ray powder diffraction to identify the form, confirm phase purity and quantify crystallinity, including detection of trace crystalline or amorphous content.
DSC and TGA to establish melting, transitions, desolvation, solvent and water content and decomposition, interpreted together rather than separately.
Polarizing light microscopy, scanning electron microscopy with EDX and hot-stage microscopy to observe particle habit, agglomeration and behaviour on heating.
Particle size and shape distribution, specific surface area by BET and powder flow behaviour by rheometry.
Dynamic vapour sorption and Karl-Fischer titration to establish hygroscopicity, hydrate formation and water content.
Chromatographic and spectroscopic purity determination, elemental impurities by ICP-MS and structural confirmation by NMR.
The technique set is chosen for the question, and extended when the first results raise a new one.
We establish what the characterization has to resolve — batch equivalence, form confirmation, an unexplained result, a full qualification — because that determines the technique set.
A first pass by diffraction, thermal analysis and microscopy usually locates the issue and tells us where to look more closely.
The techniques that address the specific question are applied in depth, including solid-state NMR, spectroscopy, surface and particle analysis as required.
Conclusions are checked against independent techniques, so that no finding rests on a single measurement.
Results are compared against reference material, previous batches or specification, and interpreted in the context of your process.
A detailed technical-scientific report with raw data, interpretation and, where relevant, recommendations for process or specification.
The laboratory holds a solid-state and analytical platform assembled specifically for pharmaceutical material science.
The output is a detailed technical-scientific report in which every conclusion is traceable to the data behind it.
Yes, and it is one of the most common requests. A side-by-side characterization across diffraction, thermal analysis, microscopy and particle properties usually locates the difference, and often explains it.
Yes. Quantification of minor crystalline or amorphous content is possible, and where diffraction reaches its limit, solid-state NMR and thermal analysis extend it. We state the detection limit of the methods used rather than leaving it implicit.
The laboratory holds GMP certification issued by AIFA and has been inspected by the FDA. Characterization can be run under GMP or as development work, depending on how the data will be used — we agree which before starting.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
Turnaround depends on the techniques involved, the number of samples and whether methods already exist. We agree the timeline with you when the work is scoped, and tell you early if anything threatens it.
It depends on the techniques involved and on how many determinations are required. We confirm the exact quantity when we scope the work, and design the analytical plan around the material you have.
A detailed technical-scientific report with the methods used, the raw data, the results and their interpretation, suitable for inclusion in development and regulatory documentation.
Work starts only after a confidentiality agreement is in place. Samples, data and reports remain yours and are never shared or reused.
Tell us the question, not just the technique. We will propose the characterization that answers it.