Raman-HPLC Combination

Detection of difficult components in analytical and preparative HPLC

  • Distinction of different oligomers and separation of biotechnological API such as peptides, carbohydrates etc.
  • Element-specific detectors for phosphor, sulfur…
  • Chiral components
  • Impurity characterization
    • API side components
    • Stability testing by-products (hardly identifed via LC-MS stanards)
  • HPLC column management
    • via actual separation results instead of defined retention times which is less and less reproducible with increasing age of HPLC columns
High Pressure Liquid Chromatography
  • Standard separation technology for soluble, UV- sensitive components
  • manyfold separation techniques
  • very small amounts detectable
Raman Spectroscopy
  • solid and solved samples possible
  • also non-UV-detectable compounds
  • Distinction of different structures at same retention time

HPLC and Raman Detection:
Very powerful combination of two excellent technologies

Separation of biotechnological API such as peptides, carbohydrates etc.

Reliable continuous detection of chiral components, impurities etc.

Characterization of Active Pharmaceutical Ingredients (API)

Complementary results to standard analytical methods

  • DSC, X-Ray Diffraction (XRD)
  • NMR Spectroscopy

Intellectual-Property-related API characterization

  • Different co-crystals of the same API (e.g. solubility enhancing)
  • Polymorphism (improved traceable court-proof compared to XRD)

Characterization of Pharmaceutical Formulations

Quantification of ingredient

  • API (also conformity, optical activity)
  • Retardating agents, excipients

Homogenity of pharmaceutical formulation

  • Inhomogenity, degree of distribution/ tablet decomposition
  • Agglomeration behavior of excipients (phospholipids, liposomes, lecithin): mycelium formulation, solution properties, emulsifying behavior etc.

Aerosols and Inhalation Systems

  • Release behavior of API from carrier materials and comparison of generic and originator formulations
  • e.g. aerosols with API on lactose: Distinction agent – carrier to grain size of 2 µm
Biotech Products
  • Characterization of proteins as two component systems
  • Solvent – protein interactions
    • concentration effects
    • Associates, hydrogen bonds
  • Protein – temperature interactions
    • e.g. change of secondary structure at different temperatures
Reaction Control
  • Comparison of biosimilars with biological API of originator (product and process parameters)
  • Comparison of protein conformation in solution of different samples/ reactions
  • Glycosylation

Data Analysis Software/Services

Open, transparent data analysis models

  • Non-proprietary
  • Well documented

Parameterized software basis package for spectrometer/ instrumentation suppliers

  • Innovative spectrometers with multiple wavelengths
  • Combinations of Raman with further methods such as SEM-EDX

In general: Data Analysis Know-how integrated in all pharma applications 1 – 4