Method Development >> Characterization >> Characterization for Pharmaceutical Products

Characterization for Pharmaceutical Products

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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 provides cGMP compliant characterization testing for pharmaceutical products to support formulation or process development, quality control, cGMP 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
  • Finished products
  • Development materials
  • Intermediate in-process materials
  • Mixtures
  • Active pharmaceutical ingredients
  • Stability study samples
  • Unknowns for identification or confirmation

Characterization Testing Capabilities

Carbon, Hydrogen & Nitrogen Analysis (CHN Elemental Analysis)

  • Determines the mass fraction of Carbon, Hydrogen and Nitrogen content
  • Rapid analysis time
  • Requires very little sample – less than 10 mg /li>

Differential Scanning Calorimetry (DSC)

  • Characterizes via thermal properties
  • Measures heat flow into and out of the sample
  • Phase transition determination

Thermogravimetric Analysis (TGA)

  • Measures the change in sample mass as a function of temperature and/or time
  • Degradation - loss in oxidation/reduction
  • Moisture/Solvent loss [LOD on micro scale]

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

  • Fingerprinting identification to known scan
  • Functional group identification within the molecular structure
  • Simple preparations non-destructive

Ultraviolet-Visible Absorption Spectroscopy (UV/VIS)

  • Identification confirmation
  • Quantitation
  • Detection of known impurities

X-ray Powder Diffraction (XRPD)

  • Identification of crystalline or semicrystalline material fingerprinted to a known scan
  • Degree of crystallinity
  • Phase analysis
  • Impurities detection

Metals testing

  • Determine the non-organic elemental mass fraction content
  • Inorganic impurities testing
  • ICP-OES, ICP-MS

Mass Spectrometry (MS)

  • Measures mass of parent compound or daughter ions
  • Accurate mass and fragmentation MS capabilities
  • Confirms molecular weight (identification)
  • Evaluation of unknown impurities