Magellan Pharmaceutical Development offers a complete line of structural chemistry
services including Mass Spectrometry, NMR and Physical Organic Chemistry. Magellan specializes
in impurity profiling, degradation chemistry and impurities related to analytical
methodology and container closure systems. The Structural Chemistry laboratory is
dedicated to providing state-of-the-art services. With a significant amount of expertise
in the regulatory area, we can assist with FDA deficiency letter responses and filings.
Additionally, Magellan Pharmaceutical Development can serve as scientific support during FDA meetings.
For more information, please give us a call with any questions or submit a project to us online.
Analytical Services
- Structural Chemistry
- Structural Elucidation Of Drug Related Impurities And Degradation Products
- Extractables/Leachables Identification and Quantitation
- Metered Dose Inhalers (Nitrosamines, PNAs, General Extractables)
- Dry Powder Inhalers
- Nasal Inhalers
- Devices
- Migration Studies
- Specification and Control Strategies
- Consultation
- Specifications
- Regulatory
- Methodology
Capabilities
- Gas Chromatography/Mass Spectrometry (GC/MS)
- Analysis with Electron Ionization (EI)
- Analysis with Chemical Ionization (CI)
- Liquid Chromatography/Mass Spectrometry (LC/MS and LC/MSn)
- Analyses with Electrospray (ESI) and Atmospheric Pressure Chemical Ionization (APCI)
in either positive or negative ion modes
- Direct Insertion and Desorption Probes for analysis of pure compounds in either EI or CI, in positive or negative ion modes
- Liquid Secondary Ion Mass Spectrometry (LSIMS) for analysis of higher molecular weight or thermally unstable compounds
- Nuclear Magnetic Resonance (NMR) Spectroscopy
- Multidimensional Homo- and Heteronuclear NMR
- Liquid Chromatography interfaced Nuclear Magnetic Resonance Spectroscopy
- (LC-NMR)
- Physical Organic Chemistry
- Semi-preparative Gas and Liquid Chromatography
- Small scale organic synthesis
- Comprehensive degradation chemistry program
- Gas Chromatography (GC)
- Headspace Testing
- Variety of detection capabilities, such as Flame Ionization (FID) and Thermal Conductivity (TC).
