Medical and Pharmaceutical Science

Nuclear magnetic resonance (NMR) spectral analysis can provide abundant information to support drug development and manufacturing. It provides detailed molecular structure information, helps to identify and determine the identity of drug substances and impurities, and also provides powerful information about the advanced structure of biological agents such as proteins and biosimilars.

As an expert in the field of nuclear magnetic resonance, the experienced experimental team of Creative Biostructure provides comprehensive pharmaceutical NMR analysis services for characterizing small molecules, macromolecules and product impurities in pharmaceuticals, biopharmaceuticals, and organic molecules.

Our Technology and Experiment Design

Structure identification of active components of pharmaceuticals

• ¹H and ¹³C spectra
• Two-dimensional homonuclear spectrum (COSY, TOCSY, NOESY, ROESY)
• Two-dimensional heteronuclear spectrum (HSQC, HMQC, HMBC)

Determination of pharmaceutical quality and composition

We use quantitative NMR technology to determine the quality and composition of the drug. Quantitative NMR mainly depends on the integral area of the proton peak in the ¹H spectrum. The content of the substance to be measured is accurately obtained by taking the internal standard reference substance with clear content as the standard.

If there is a standard, we can also determine the existence and relative content of impurities by collecting ¹H and ¹³C spectra and comparing them with the standard.

Quantitative NMR depends on the integral area of the H spectral peak, and its accuracy ultimately depends on the signal-to-noise ratio of the signal peak baseline, linearity, shimming, selection of peak shape processing function, phase, baseline and other factors. These can be achieved through our standardized experimental operation and parameter optimization to ensure its linearity, stability, reproducibility, accuracy and selectivity.

Types of Pharmaceuticals that can be Analyzed

• Polymeric pharmaceuticals

The detection of polymeric pharmaceuticals is limited by their high molecular weight and the difficulty of obtaining standard products. Conventional chromatographic techniques are difficult to identify such pharmaceuticals, while NMR method is completely unaffected by its influence and can still be used for qualitative and quantitative research.

• Multicomponent pharmaceutical

NMR can evaluate the relative content of each component with a similar structure in multi-component pharmaceuticals and determine the composition proportion of each component by determining the integral area of the characteristic spectral peak in different resonance systems.

• Sugar vaccine
• Peptide pharmaceuticals

Service Content

Our NMR analysis services include:

• One-dimensional and two-dimensional homogeneous/heterophase NMR experiments were used to comprehensively characterize organic molecules.
• Experienced consultants interpret complex NMR data.
• Polymer analysis, including ¹³C qualitative and quantitative determination.
• Identification of unknown objects.
• Identification, confirmation, and quantification of API (active drug ingredient) in drugs (tablets, capsules, etc.)
• Analysis of counterfeit drugs.
• Purity or concentration determination of drugs-pharmaceuticals. Internal standards are used for content or purity measurement.
• Identify or confirm the structure of organic species.
• Identification and quantification of impurities in organic species.

Our Featured NMR Pharmaceuticals Analysis Services

• Molecular Dynamics Studies of Pharmaceutically Active Peptides
• Determination of Disulfide Bond Connectivities in Pharmaceutical Peptides
• Characterization of Antimicrobial and Host-Defense Peptides
• Characterization of Peptide Toxin Structure and Function
• NMR-Based Metabolic Phenotyping
• Determination of G-Quadruplex Complex Structures
• NMR Spectroscopy in Fragment-Based Drug Design
• Isotopic Analysis by NMR and Applications for API Traceability
• Reaction Kinetics Examination
• Mapping Structure of Biological Drugs
• NMR Analysis for Biopharmaceutical Development
• Analysis of Drug Delivery Systems

Advantages of NMR Pharmaceuticals Analysis Services

• It hardly needs sample preparation time and can provide a comprehensive report in about a week.
• The experiment has no damage to the analytical sample, and it can obtain nondifferential structural information feedback for the active components and impurities in the sample.
• The mixture is rapidly analyzed at the molecular level without separation and/or purification steps.
• We can customize customized solutions for you according to your samples. You can select or suggest the required items for analysis.

Creative Biostructure is committed to providing high-quality NMR analysis services to advance the life sciences fields. If you have any questions or needs, please contact us and our customer service staff will help you the first time.

Ordering Process