Pharmaceutical Physical/ Chemical Characterization Services

Characterization XRD

Characterization testing is used to gain an understanding of the physical and chemical properties of pharmaceutical materials. During process and drug development, these properties can have an impact on the product’s performance, ability to be processed, stability and appearance.

Eurofins BioPharma Product Testing network of laboratories provides cGMP compliant and non-GMP investigational characterization testing for pharmaceutical materials to support formulation, process development, quality control, GMP lot release testing, and investigational manufacturing troubleshooting. We have extensive experience with an array of product types from raw materials to active pharmaceutical ingredients and can accommodate virtually any product type.

Why Choose Eurofins BioPharma Product Testing?

Our extensive experience with a variety of techniques and sample types lends the ability to tailor the testing to meet specific client requirements at one testing location.
We have developed a host of in-house general methods for a variety of techniques to eliminate the need to develop a method from scratch. We can also follow compendial or client-provided methods, per cGMP, as well as develop new methods when no current method exists.

Sample Types

We have experience with a variety of sample types, including:

Raw materials
Development materials
Intermediate in-process materials
Active pharmaceutical ingredients
Stability study samples
Unknowns for identification or confirmation

Physical Characterization Testing Capabilities

Surface Area

Calculates BET surface area: single or multipoint
Measures the total pore volume or porosity as well as the pore size by gas absorption/desporption
Krypton capable to measure surface area as low as 0.001 m²/g
Predicts reactivity, dissolution and compactness

Dynamic Vapor Sorption

Measures rate and ease of water permeation, hygroscopicity, deliquescence point, water activity
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 (DSC)

Determines phase and structural transition between -90 to 400°C
Directly measures heat capacity
Analyzes complex and overlapping thermal changes - modulated DSC capable
Detects weak thermal changes

Thermogravimetric Analysis (TGA)

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

X-ray Powder Diffraction (XRPD)

Identifies crystalline or semicrystalline structure
Analyzes degree of crystallinity, amorphicity
Detects impurities

Particle Size & Zeta Potential

Measures particle sizes from 0.01 μm to 3,500 μm, zeta potential from 0.3 nm to 10,000 nm
Capable of analyzing wet dispersion and dry dispersion
Determines diverse sample types: abrasive, fragile, cohesive or agglomerated

Physicochemical Properties

Determination of Acid Dissociation Constant (pKa), Partition Coefficient (Log P), Distribution Coefficient (Log D)

Chemical Characterization Testing Capabilities

Fourier Transform Infrared & Near-Infrared Absorption Spectroscopy (IR [FTIR, NIR])

Fingerprinting identification of known scan
Identifies functional groups within the molecular structure
Determines protein secondary structure
Identifies resins and opaque/colored materials using photoacoustic scans

Ultraviolet-Visible Absorption Spectroscopy (UV/VIS)

Determines characteristic absorption patterns
Used for qualitative detection, quantitative calculation and kinetic analysis
Measures Molar Extinction Coefficient (MEC)

Carbon, Hydrogen & Nitrogen Analysis (CHN Elemental Analysis)

Determines the mass fraction of Carbon, Hydrogen and Nitrogen content

Metals Testing (ICP-MS)

Trace level quantitation of most elements in liquid and solids

Mass Spectrometry (GC-MS, HPLC-MS)

Measures mass of parent compound or daughter ions
Accurate mass and fragmentation patterns
Confirms molecular weight (identification)
Evaluation of unknown purities

Nuclear Magnetic Resonance Spectroscopy (NMR)

Solid state characterization: crystal polymorphism, ID, limit, and Impurity
Capable of qNMR and 3D-NMR
Compound library enables high-throughput QC, protein ligand NMR binding assays

Instrumentation

Micromeritics Tristar II Confirm Surface Area
TA Instruments Q5000 SA Dynamic Vapor Sorption
TA Instruments TGA Q500
TA Instruments Discovery DSC 2500
TA Instruments Nano DSC
Malvern Mastersizer 3000 PSD
Malvern Zetasizer Ultra
Malvern Zetasizer Nano Series ZS90
Bruker D8 Advance XRD
Agilent 7900 ICP-MS
Bruker Alpha II FTIR with Platinum Diamond ATR
Thermo Nicolet 6700 FTIR
Shimadzu UV-2700
Agilent 8453/8454 UV-Vis
400MHz WB Avance Bruker with 19F-NMR setup
500MHz NMR Bruker Avance III, BBFO probe and TCI cryoprobe, SampleJet
400MHz NMR Bruker Avance III, BBFO probe (1H, 13C, 31P, 19F), SampleJet

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