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Physical & structural characterization

Physical & structural characterization

ALS offers a broad range of analytical techniques and expertise to characterize the physical and structural features of excipients, APIs, and finished products.

Understanding the physical properties of pharmaceutical raw materials is key to successful drug product development and performance. Physical properties such as size/shape, morphology, particle size distribution, flow, density, dissolution profile, bioavailability and melting point enable more efficient formulation and manufacturing process development at the drug product stage. These factors contribute to the evaluation of drug-excipient compatibility (which affects physicochemical stability) and physiological bioavailability.

Physical characterization techniques and services available at ALS include:

Nuclear magnetic resonance (NMR) spectroscopy

ALS has advanced NMR laboratories, where comprehensive structure elucidation expertise is coupled with state-of-the-art analytical techniques.

NMR measurements are performed on one of five Bruker instruments, with up to 600 MHz equipped with CryoProbe technology. 2D NMR Services are also available.

Scanning electron microscopy

Scanning electron microscopy (SEM) is a powerful imaging technique that is superior to traditional light microscopy in many ways. It can provide topographical and compositional information and can be applied to examine and characterise a wide range of pharmaceutical materials in their various formats.

SEM can be a helpful analytical and investigative tool in:

ALS can support testing in line with the requirements and principles set out by Ph. Eur. method 2.9.52 and USP <1181> using SEM-EDX at facilities in Sweden and Singapore.

Water activity determination

Water activity (aW) analysis measures available water in a product that could facilitate the growth of microorganisms. The water activity of a product can be used to predict microbial growth and ultimately determine the microbial stability of the product. Released in May 2021, the newer USP Method < 922 > outlines best practices in Water Activity Determinations. It includes the recommendation for matrix-specific method verification; the chapter specifies a number of known potentially impactful sensitivities in the Determination of Water Activity.

ALS widely supports Water Activity testing of pharmaceuticals, and the verification thereof, per USP < 922 > and Ph. Eur. 2.9.39 methods. In addition, practical assistance can be provided to help implement the principles behind the Application of Water Activity Determinations to Nonsterile Pharmaceutical Products per USP < 112 >