Element’s Nuclear Magnetic Resonance (NMR) Spectroscopy analysis supports critical stages of pharmaceutical development.

NMR Spectroscopy enables verification of chemical synthesis and compound characterization. It provides information about a molecule covalent structure, stereochemistry, and conformation, helping to establish or confirm the identity of pharmaceutical substances or related impurities.

NMR is also a valuable tool for both absolute and relative quantitative measurements, which allow the determination of impurity in a drug substance or excipient, ensuring your product meets regulatory requirements. Quantitative measurements through NMR analysis establish the co-monomer ratios in polymers as part of the characterization process, or the degree of substitution of polymers or carbohydrates. Mixtures of compounds are often amenable to NMR analysis as well.

Our Nuclear Magnetic Resonance Spectroscopy services include:

  • Heparin Sodium impurity determinations
  • Identification, co-monomer ratios and residual monomer analysis of biodegradable polymers such as PLGA
  • Determination of weight percent oxyethylene in poloxamers
  • Olefins in crude oils and condensates
  • Deacetylation degree of polysaccharides such as Chitosan
  • Confirmation of synthetic peptide sequence
  • Complete structural elucidations of Active Pharmaceutical Ingredients (API) and naturally occurring compound and in-process impurities

Structural elucidations studies involve 1D, 1H, 13C, 31P and 19F NMR in combination with 2D {1H, 1H} (COSY, TOCSY, NOESY), 2D {1H, 13C} and {1H, 15N} HSQC and HMBC and 2D {19F, 13C} HSMBC experiments.

Element’s laboratory provides a Good Manufacturing Practice (cGMP) compliant NMR operating system for cGMP NMR development, consulting and testing services. You can count on Element for fast, precise results that are right the first time and support pharmaceutical development. 

To learn more about NMR spectroscopy in pharmaceutical analysis, or to speak with one of our experts, contact us today.

 
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