Solubility, ionization, particle size, morphology, water content, density, viscosity, thermal behavior, crystallinity, partitioning, and other physicochemical properties influence formulation design, processing, storage, stability, and product performance. These values are not fixed constants; they can change with temperature, humidity, solvent, impurities, solid form, and sample history. Triclinic Labs selects and combines fit-for-purpose physicochemical, spectroscopic, thermal, moisture, particle, and solid-state methods to establish material-property profiles that support development decisions, raw-material qualification, investigations, formulation strategy, and regulatory documentation.
Physical and chemical property analysis measures material attributes such as melting and boiling points, glass-transition temperature (Tg), density, pH, pKa, logP/logD, solubility, stability, crystallinity, particle size, surface area, porosity, morphology, flowability, water content, and related properties.
Use it when development needs a property profile for identity, formulation, storage, processing, dissolution, comparability, impurity investigation, or raw-material qualification.
Property values depend on method, solvent, temperature, humidity, sample form, impurities, and history. Apparent properties can reflect a metastable solid form or formulation state rather than intrinsic molecular behavior.
Sample amount depends on technique, matrix, replicate needs, detection limit, current good manufacturing practice (cGMP) requirements, and whether method development or validation is required. Confirm exact amounts at project intake.
Complementary techniques are selected around the property that controls the decision and may include chromatography, mass spectrometry, nuclear magnetic resonance (NMR), X-ray powder diffraction (XRPD), thermal analysis, dynamic vapor sorption (DVS), Karl Fischer titration, ultraviolet/visible (UV/Vis) spectroscopy, elemental analysis, particle-size analysis, and microscopy.
FDA-facing work should connect the method to a quality attribute, document sample preparation and specificity, and support validation or verification where the result is used for release, stability, or regulatory decisions.
Common mistakes include reporting instrument results without explaining what they mean for the material or project decision.
Triclinic uses physical and chemical property measurements to connect material attributes to formulation, processing, storage, and developability decisions. Real-world applications include solubility and dissolution support, hygroscopicity and moisture-risk assessment, pH or ionization-related questions, compatibility screening, and investigations where a property change explains performance, stability, or manufacturability differences.
The table below lists the specific platforms, models, software, methods, and capability notes relevant to this service area.
| Instrument or platform | Platform, model, software, or method | Additional capabilities and use |
|---|---|---|
| Dissolution testing | VanKel VF750D dissolution platform with ultraviolet/visible (UV/Vis) or high-performance liquid chromatography (HPLC) detection | Dissolution profiles, in vitro release support, bioavailability-relevant release comparisons, and USP <711>-style method support. |
| Polarimetry | Rudolph Autopol V Plus with Embedded Polarimeter Software v.3.2.6.1006 | Optical rotation, chirality-related purity checks, concentration support, and rapid identity/purity screening. |
| Contact-angle / wetting analysis | Rame-Hart imaging system with Drop Image Advanced Software v.1.4.11 and automated dispensing system | Contact angle, surface wetting, powder wettability, hydrophilic/hydrophobic classification, and formulation surface-property support. |
| Bulk and tapped density | Caleva TDT 12 | Bulk- and tapped-density measurements under USP <616> to support powder packing, flow, formulation, and manufacturing decisions. |
| Angle of repose | Controlled angle-of-repose powder-flow method | Rapid, non-destructive powder-flowability assessment supporting excipient selection, process development, and quality investigations. |
| Particle-size distribution | Malvern Mastersizer 3000 with Hydro MV, Aero S, and Hydro Insight | Wet and dry particle-size distribution with dynamic particle-imaging support for agglomeration, morphology, formulation, and manufacturability questions. |
| Disintegration testing | Testerion DT2 | Disintegration behavior of tablets and hard-gelatin capsules under standardized conditions. |
| Powder flow | Hall FlowMeter AS-300 | Powder flow-rate and apparent-density information for processing and formulation decisions. |
This example organizes physicochemical services into a project-scoping table. Physicochemical testing is useful when identity, formulation performance, raw-material control, storage behavior, or development troubleshooting depends on properties rather than only chemical composition. The right test set depends on the attribute that must be controlled.
| Property or test family | Example decision supported |
|---|---|
| pH, pKa, logP/logD, solubility | Salt selection, formulation vehicle selection, dissolution risk, or partitioning behavior. |
| Melting point, DSC/TGA, crystallinity | Solid-state identity, stability risk, compatibility, or phase-transition interpretation. |
| Density, particle size, morphology, viscosity, flowability, wettability | Manufacturing processability, dispersion behavior, powder or liquid handling, and formulation performance. |
| Water content, hygroscopicity, KF, DVS | Hydrate risk, packaging, water-driven stability, and storage-condition decisions. |
| Optical rotation, elemental microanalysis, spectroscopy, MS, NMR, XRPD | Identity, purity, impurity profile, or orthogonal confirmation of a material attribute. |
These examples include technical resources, regulatory guidances, or literature relevant to the technique. Download buttons are placed at the bottom-left of each example.
Author: Melanie Bevill, Chris Seadeek, Nico Setiawan, Shawn Comella, Blaise Mibeck, and Steef Boerrigter
Publication date: November 2023
Abstract: Solid-form screening and selection connect crystallinity, stability, solubility, hygroscopicity, manufacturability, regulatory needs, and IP objectives. Analytical techniques should therefore be selected according to the development decision rather than a fixed instrument list.
Author: International Council for Harmonisation / FDA
Publication date: 2024
Abstract: FDA notes that ICH Q2(R2) and Q14 describe validation and development principles for analytical procedures used to assess drug substance and drug product quality. These guidances frame FDA expectations for specificity, accuracy, precision, range, robustness, lifecycle management, and fit-for-purpose method evidence.
Author: International Council for Harmonisation
Publication date: 2022
Abstract: ICH Q3D(R2) provides the risk-management framework for assessing and controlling elemental impurities in drug products. It is the regulatory anchor for elemental-impurity testing, method selection, and justification of ICP-MS, XRF, or other elemental-analysis strategies.
Characterizes density, flow, particle size, moisture response, surface behavior, and morphology to explain powder handling and manufacturing performance.
View techniqueIdentifies crystalline phases and solid forms, measures crystallinity, and tracks polymorph, hydrate, solvate, or salt changes.
View techniqueDetermines molecular and crystal structures from sub-micron crystals when conventional single-crystal analysis is not practical.
View techniqueMeasures melting, glass transitions, crystallization, solvent loss, and decomposition to connect thermal behavior with stability and processing.
View techniqueQuantifies water, distinguishes bound from surface moisture, and evaluates sorption, desorption, hydrate formation, and humidity-driven change.
View techniqueProvides rapid molecular-identification, functional-group, solid-form, mixture, and spatial-distribution evidence using Raman, FTIR, IR imaging, and UV/Vis.
View technique
Tell Triclinic what sample you have, what decision the data must support, what prior data are available, and whether cGMP, release, validation, or regulatory documentation is required.
