Polymorphism analysis and solid-state characterization
What is polymorphism?
In chemistry, polymorphism is the ability of a chemical substance to crystallize in different structures depending on temperature and pressure conditions. These different forms derived from the same molecule can have very different physical and chemical properties. FILAB supports companies in the pharmaceutical, chemical... sectors in the polymorphism analysis of their chemical substances.
Why characterize crystal phases?
Different phases have different dissolution rates. A metastable phase might dissolve faster, while a stable phase might be poorly absorbed by the body.
Drugs can spontaneously transition from one phase to another over time. Characterization ensures the drug won't change its structure (and thus its effect) during storage.
Crystal shape and hardness affect milling, mixing, and tablet compression. One phase might flow easily through machines, while another might cause "sticking" or "capping."
Pharmaceutical companies can patent specific crystalline forms. Characterizing your phase is vital for protecting your product or avoiding litigation with competitors.
Regulatory bodies (like the FDA or EMA) require strict control of the crystalline form to ensure every tablet delivered to a patient has a consistent and predictable therapeutic effect.
FILAB performs polymorphism analysis of your chemical substances
The FILAB laboratory offers industrial companies technical expertise and state-of-the-art analytical equipment in order to respond as effectively and responsively as possible to their requests and provide them with the most suitable services and tailored support for polymorphism analysis.
Our polymorphism analysis services
Analysis of active ingredients (API) by XRD and DSC
Development of analytical methods for the quantification of polymorphic chemical substances
Advanced technical resources for polymorphism analysis
X-ray diffraction (XRD) for the determination of crystalline phases
Analyses DSC for determining melting and crystallization temperatures
Thermal analysis (differential calorimetry, thermogravimetry)
Development of analytical methods for the quantification of polymorphic chemical substances
Polymorphic screening and stability studies
FILAB conducts comprehensive polymorphic screening to identify all possible crystalline, amorphous, or solvated forms of a substance. By simulating various manufacturing and storage conditions (temperature, pressure, humidity), our laboratory determines the thermodynamic stability of each phase. This is essential for preventing unwanted transitions – such as a powder turning into a different crystal form during compression or a suspension recrystallizing over time.
Impact of polymorphism on bioavailability and solubility
In the pharmaceutical industry, the crystal form of an Active Pharmaceutical Ingredient (API) directly dictates its therapeutic efficacy. A polymorphism laboratory identifies which crystalline structure offers the optimal dissolution rate and bioavailability. Since different polymorphs have varying lattice energies, one form may be more soluble but less stable than another (metastable forms). Failure to monitor these variations can lead to inconsistent drug performance or shelf-life issues.
Our FAQ
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
Yes. Our polymorphism laboratory uses high-resolution XRD and Raman spectroscopy to detect and quantify low levels of polymorphic impurities, ensuring the purity of your crystalline phase.
Absolutely. REACH registration requires accurate substance identification. Furthermore, characterizing a specific polymorph is often a key component of pharmaceutical patents and "sameness" studies for biosimilars.
