Physical & structural characterization

Physical characterization techniques and services available at ALS include:

• Particle size distribution By Laser Diffraction (Mastersizer-3000) both in dry and wet mode
• X-Ray Powder Diffraction (XRPD) - By Pan Analytical - testing crystalline and amorphous ratio for APIs and excipients.
• Differential scanning calorimetry (DSC) - Determines phase and structural transition and test heat capacity
• Thermogravimetry (TGA) - Determines rate of chemical degradation at various temperatures
• Melting Point - To identify a substance and its purity.
• Infrared spectroscopy - Scanning and Identification of functional groups within the molecular structure.
• Water Activity – Determines product safety and stability with respect to microbial growth chemical/bio chemical reaction rates and physical properties (further detail below)
• Scanning electron microscope (SEM) – At ALS Singapore Lab / Obtaining three dimensional like image of the surface to study the catalytic activity and its property.
• NMR spectroscopy and Mass Spectrometery can be offer via our partners NUVISAN
• Bulk and tap density Testing

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:

• Monitoring non-viable particles in cleanrooms
• Fiber identification in dust and materials
• Physical and chemical analysis of samples
• Particle imaging and particle size analysis
• Investigation of complaints
• Analysis and identification of particulate matter contamination (also known as "foreign bodies")
• Assistance in troubleshooting manufacturing problems

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 >