Compliance Systems                                                               Back
With the implementation of the FDA’s Process Analytical Technology initiative, pharmaceutical companies will be responsible for monitoring every step of their production process.  This includes  all chemical structures, including stereo configuration,  if applicable, and all intermediates (either in-situ or isolated) and significant side products as well as solvent, catalysts and reagents.  Monitoring at selected stages in the synthesis or manufacturing process to assure reaction completion and purity or proper cell growth will become routine.  Trace impurities, wherever they arise, must be identified quickly to keep critical processes running smoothly.  

 

 

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Supported Operations

  • Electrofocusing using SPUR
  • Micro-Solid Phase Extraction
  • High Throughput Sample Loading to MicroFlow NMR
  • MicroTrap MS Confirmation (avail.2006)

Supported Studies

  • Time Profiling
  • Stability/ Degradation   (e.g., temperature, oxidation)
Impurities Identification
Amethyst (the iron impurity creates the violet color) Now you can use NMR!  MicroFlow NMR probes make routine impurity detection, structure elucidation and quantitation possible using small amounts of sample and small amounts of your valuable instrument time!Identify impurities from:

  • Raw materials (e.g., unknown contamination)
  • Reaction Byproducts (quantification below threshold)
  • Degradation Products (e.g., oxidation, thermal decomposition)
  • Polymer leachables from packaging
Stability Profiling
Protasis can automate entire stability test protocols to cycle drug leads, food and beverage or materials of commerce through a range of temperature, pH, relative humidity, light, oxidation, dissolution or catalytic conditions to see how new products hold up over time.  Study protocols can be scheduled over time to acquire data under a full set of multi-dimensional conditions.  Data reduction complete with plotting and rate determinations can be provided with full software acquisition, control, analysis and reporting in a fully integrated platform.  Lot to lot comparisons can be made.  Integrated MicroFlow NMR allows you to characterize degradation products quickly even when present at only trace levels.
Isolate Trace Impurities with CapLC
Waters CapLC gives you the highest separation resolution and peak capacity.  Those ultra-sharp capillary chromatography peaks provide the wide dynamic range you need to isolate and concentrate trace impurities in the presence of your active ingredients.