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Analytical Services

Hexagon Scientific Services (HSS) has broad experiences in Analytical Method Development, Analytical Method Validation, Identification and Characterization of Drug Substance, Drug Product, Intermediates and Degradants, Impurity Profiling and Polymorphism Study. HSS is competent to assist and support in all CMC related activities. HSS offers services for reviewing your analytical procedures to ensure that methods are appropriate for their intended purpose. We can advice to establish new analytical procedures or troubleshoot and improve existing methods. This can be carried out at your own laboratory or in partnership with analytical CRO. Our experience encompasses all types of analytical methods, scientific techniques to characterize of your products, plus a few with which you may be less familiar with. HSS offers consultancy services and finding remedies for your troubles in the following areas:

  • Analytical Method Development.
  • Chromatography Techniques.
  • Spectroscopy Techniques - NMR, MS, FT-IR, UV (DRS), NIR and SEM-EDS.
  • Thermal methods of analysis- DSC and TGA.
  • Solid State Chemistry (Polymorphism) and Partic Size Distribution (PSD) analysis.
  • Trace Metal Analysis using AAS, ICP-OES and ICP-MS.
  • Impurity Profiling of Drug Substance and Drug Products.
  • Supplying Innovator Prodcuts, API Impurities, Degradation Products, and Metabolites.
  • Structural characterization of Drug substances, Intermediates and Impurities.
Spectroscopy Techniques and Thermal Methods of Analyses

HSS has extensive experience in characterizing API's, Raw Materials, Intermediates, and Degradants by using spectroscopic techniques and thermal methods of analyses. HSS can assist you to characterize and elucidation of chemical structures by using those techniques. Also, HSS provides, FDA acceptable, a detailed "Chemical Structural Elucidation Reports" for APIs, Raw Materials, Impurities and Degradants along with the details of interpretations related to spectroscopic and Thermal methods of analyses.

1D NMR Techniques:
  • 1 H NMR & D2O Exchange, 13C NMR, 19F NMR, 31P NMR, DEPT.
  • 1D NOE technique.
  • NMR Assay to determine the purity of a compound.
2D NMR Techniques:
  • Homo nuclear correlation spectroscopy through bond: COSY and TOCSY.
  • Homo nuclear correlation spectroscopy through space: NOESY and ROESY.
  • Heteronuclear correlation spectroscopy (short range coupling): HSQC, HMQC.
  • Heteronuclear correlation spectroscopy (long range coupling): HMBC.
Regulatory
Regulatory
Mass Spectroscopy:
  • High Resolution Mass Spectroscopy (HRMS).
  • Liquid Chromatography-Mass Spectroscopy (LC-MS).
  • Gas Chromatography-Mass Spectroscopy (GC-MS).
  • Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS).
  • Gas Chromatography-tandem Mass Spectrometry (GC-MS/MS).
Other Spectroscopy Techniques :
  • Infrared Spectroscopy.
  • Raman Spectroscopy.
  • UV and Visible Spectroscopy.
  • Atomic Absorption Spectroscopy (AAS).
  • Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES).
  • Scanning Electron Microscopy (SEM-EDS).
Solid State Characterisation (Polymorphism) :

HSS has well experience in Polymorphism Study in drug product and drug substance. HSS assists you for carrying out the comprehensive Literature Survey including Patent Search. By using PXRD, DSC, TGA and SEM, we will support customers for the complete Polymorphism study.

  • Differential Scanning Calorimetry (DSC).
  • Thermo gravimetric Analysis (TGA).
  • Hot Stage Microscopy (HSM).
  • Single Crystal and Powder X-ray Diffractometry (PXRD).
  • Scanning Electron Microscopy-Energy Dispersive X-Ray Spectroscopy (SEM-EDS).
  • Qualitative Identification of Polymorphs using PXRD/DSC/TGA and FT-IR techniques.
  • Quantification using PXRD, FT-IR and DSC- Method development and Validation.
  • Identification of Hydrates and Solvates using PXRD/TGA/DSC and DVS studies (Dynamic Vapor Sorption Analysis).
Regulatory
Analytical Method Development

HSS has extensive experience in developing analytical methods and its validation by using various chromatographic techniques such as liquid chromatography (HPLC), Gas chromatography (GC), AAS, ICP-MS, NMR-Assay, ICP-OES, PXRD, DSC/TGA and PSD (Particle Size Distribution).

Unknown Identification-Forensic Sample Identification

Unknown contamination/Forensic Sample can be identified and characterised by using various Microscopy (SEM-EDS/Optical and Polarising Microscopy, Hot Stage Microscopy) and using various traditional Spectroscopy Techniques like Raman and FT-IR.

Impurity Profile for Drug Products and Drug Substances

HSS specialized in identification, characterization and quantification of degradation products and related substances (derived from route of synthesis) present in Drug Substance and Drug Product. HSS has collaboration with several analytical laboratories in equipped with latest sophisticated state-of-the-art instruments like NMR, LC-MS/MS, LC-NMR, GC-MS/MS, HPLC, GC, IC, DSC, FT-IR etc to carry out relevant analysis for characterization and quantification of Impurity present in the given drug substances and drug products. HSS also undertakes consultancy projects for complete ' Impurity Profiles ' analysis. HSS provides a complete report with all necessary spectral interpretation and characterization data.