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Small Molecule API and Intermediates CDMO Services

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Small Molecule API and Intermediates CDMO Services

Quality Studies and Analytical R&D

Porton’s highly skilled and experienced analytical R&D teams provide our clients with a full spectrum of RSM/INT/API development, validation, stability study and testing services that fully meet global IND/NDA regulatory expectations and client needs at different stages of drug development.

Method Development, Verification and Validation

  • IND/NDA filing readiness; method development report; method monographs; validation reports per ICH guidelines.
  • Systematic method screening system for rapid establishment of stability-indicating assay/impurity analysis method
  • Chiral impurities and purity analysis methods (Chiral Method by HPLC or SFC)
  • Counter-ion analysis methods (Titration or IC)
  • Analytical methods for (potential) geno-toxic impurities (LC/MS/MS or GC/MS)
  • Quick compound-specific residual solvent method development using in-house generic method as starting point
  • Water Content by Karl Fischer
  • Elemental impurities scanning and control method as per ICH Q3D
  • Potency Assay or ID Test by NMR and others for qualitative analysis of impurities or impurity profile comparison work or reference standard characterization, as needed

Stability Study and Evaluation

  • Forced degradation and stress tests (Light, acid, alkali, oxidation, high temperature, and high humidity)
  • Stability test as per ICH Q1 and NMPA guidelines(40°C /75%RH,30°C /65%RH,25°C /60%RH,5°C)
  • Generate protocols and reports applicable to IND filing

Analytical Testing

  • Structural elucidation of standards and full characterization of primary standard with chromatographic purity, assay, ROI, LOD, water by KF, residual solvents etc.
  • Certificate of Analysis (COA) available
  • Preparation, structure elucidation and characterization of impurity
  • Product release testing and support for process R&D

Quality Control Strategy

  • Establishment of impurity control strategy with specification justification
  • Research and establishment of quality standards of IND/NDA filing
  • Technical support in life cycle management of analytical methods
  • QRA, DoE and QbD study support
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