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Analytical Development

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Analytical Capabilities

The analytical team at Eurofins Advinus is competent in handling various chromatographic and spectroscopic techniques. Analytical functioning is extended through method development for raw materials, in-process monitoring, intermediates and finished products and support to regulatory filings. The team is also well versed in establishing stability indicating methods, executing method validation as per ICH Q2, release analysis etc., and method transfer to the site of execution.

The team also has expertise in isolation and identification of trace impurities, structural elucidation, characterization of standards, evaluation of residual solvents and elemental impurities as per ICH Q3 and genotoxic impurities in Active Pharmaceutical Ingredients (APIs) as per ICH M7.

We also conduct stability studies with reference to ICH Q1 at various conditions of temperature and humidity to establish container closure system, storage condition and shelf life of the product.

ANALYTICAL INFRASTRUCTURE:

  • High Performance Liquid Chromatography (HPLC) with PDA, VWD, RI and ELSD detectors.
  • Ultraperformance liquid chromatography (UPLC) equipped with PDA detector.
  • Gas Chromatography with head space capabilities (GC/HS) equipped with FID, TCD and ECD detectors.
  • LC-MS and LC-MS/MS
  • Gas chromatographic-mass spectrometry (GC-MS/MS) supported with headspace sampler.
  • Nuclear Magnetic Resonance (NMR) 400 mHz equipped with BB dual probe for 1H, 11B, 13C, 19F, and 31P.
  • Supercritical Fluid Chromatography (SFC), Prep150 SFC Mgm Core with chromScope software
  • Mass directed purification system (Prep HPLC)
  • Ion Chromatography, Dionex ICS 5000+ SP
  • Differential Scanning Calorimetry (DSC)
  • Thermogravimetric Analyzer (TGA)
  • Inductively coupled plasma-mass-spectrometry (ICP-MS), Thermo Scientific ICAP RQ & Perkin Elmer NexION 350X
  • Polarimeter
  • Autotitrator
  • Infra-Red Spectroscopy
  • Stability chambers

ANALYTICAL ACTIVITIES

Analytical Method Validation / Verification and Transfer: Execution of method validation as per ICH guideline. Assistance in validating methods and transferring them to the execution site and ensuring reproducibility of results.

Stability Studies and Storage: Eurofins Advinus provides services for extended stability studies under varied temperature and humidity factors to establish ideal storage conditions, container closure and establish shelf life of APIs to meet regulatory requirement.

Forced Degradation Stress Testing: We have extensive hands-on experience in performing forced degradation studies for drug substances under acidic, basic, oxidative, photolytic, and thermal conditions and to identify and characterize potential degradation products and their formation pathways.

Identification, Isolation and Characterization of impurity:

  • Development of methods to isolate impurities in regulatory starting material, advanced intermediates, and APIs using various techniques such as flash chromatography, liquid-liquid extraction, and preparatory HPLC.
  • Structural elucidation of the isolated impurities using LCMS/MS, and NMR spectroscopy.
  • Preparation of reports for regulatory submission.

Reference and working standards qualification:

  • Preparation of working standards for raw materials, intermediates, impurities, and finished products by selecting high pure material and testing it against the available official reference/working standards.
  • Preparation and qualification of reference standards through purification, characterization and establishing mass balance of a given material in case if the official reference/working standard is not available.

Elemental / Metal Analysis:

  • Facility to directly aspirate sample solution in organic solvents
  • Microwave digestion system capable of digesting variety of samples and sample sizes
  • Laboratory with expertise in establishing accurate and precise trace and ultra-trace level analyses to meet ICH Q3D limits
  • Identification and quantification of elemental / metal composition in diversified sample types
  • Use of reference standards with traceability to international standards.