Characterization of APIs
XRPD characterization and testing
Method development (Identification, limit test, etc.) of crystalline and amorphous ratio for APIs and excipients, depending on the individual composition
Particle size determination
Particle size distribution by several techniques covering a broad range of sizes intervals ranging:
- from 2 nm to 200 nm by Malvern Dynamic Light Scattering (Zetasizer Pro Red)
- from 0.01 μm to 3,500 μm by Laser Diffraction (Mastersizer 3000) both in dry and wet mode with capability to determine the exact powder refractive index (using a refractometer instrument)
- from 50µm to 3,500 µm by mechanical sieving and Alpine air jet sieving at various meshes (Alpine e200 LS)
- Component-specific morphological descriptions of particulate blends.
- Identification of particles through Morphologically-Directed Raman Spectroscopy.
- Control both API and excipient particle size and shape during development, and throughout formulation and processing.
- Simplification of deformulation challenges for Generics to support in vitro bioequivalence.
- Detect anomalies, contaminants and pinpoint process deviations during manufacturing.
- Calculates BET surface area (single or multipoint) and determines pore size and pore size distribution within 2 to 400 nm for macro, micro or mesoporous samples
- Predicts reactivity, dissolution and compactness*
- Size and form analysis by Scanning Electronic Microscopy
- Polarised light microscopy (PLM)
Dynamic Vapor Sorption
- Measures rate and ease of water permeation
- Measures water vapor sorption – desorption isotherm
- Measures effect of sample environment on crystallinity or amorphous content
- Determines changes in flow ability, compaction density and appearance
Differential scanning calorimetry
- Determines phase and structural transition, provide heat capacity
- Analyzes complex and overlapping thermal changes – modulated DSC capable
- Measures the change in sample mass as a function of temperature and/or time
- Monitors moisture/Solvent loss (LOD on micro scale)
- Determines rate of chemical degradation at various temperatures
- Measures gas absorption-desorption
Allows to visually examine all kinds of thermal transitions when the sample is heated or cooled. Complementary to the thermal analyses (DSC and TGA).
Density & flow properties
- Determination of bulk and tap density
- Determination of powder flow ability
- Measure of repose angle
Chemical characterization testing Capabilities
(BRUKER AVANCE III 400 MHZ EQUIPPED WITH A PROBE BBO400 Z108618_0277 / 5MM)
- Identifies chemical structure
- Quantification of residual solvents
Fourier transform infrared & near-infrared absorption spectroscopy
Fingerprinting identification of known scan and Identification of functional groups within the molecular structure
Ultraviolet-visible absorption spectroscopy
- Determines characteristic absorption patterns of raw materials
- Used for qualitative detection, quantitative calculation and kinetic analysis