Old_Chemistry Capabilities
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Chemistry Capabilities
Synthetic Capabilities
  • — Precise route selection & phase-appropriate process and analytical development
  • — Process development, optimization and rapid scale-up of building blocks, key intermediates, RSMs and APIs.
  • — Expertise in DoE, Quality by Design (QbD) approach
  • — Impurity profile, fate and purge studies
  • — Critical process parameters (CPP) and critical quality attributes (CQA) evaluation
  • — Reaction modeling/simulation, DFT calculations
  • — Continuous flow and enzymatic chemistry capabilities
  • — Early phase toxicology batches, GLP tox batches
  • — Phase I and II clinical batches (cGMP) 
Solid State Capabilities
— Solubility measurement and solubility temperature curve
— Polymorph Screening 
— Salt screen and selection
— Solid state characterization
  • — Crystallization process development and polymorph control
  • — Particle size reduction and analysis



Analytical/QC Capabilities
— Analytical Method Development/Validation/transfer
—​​​​​​​ GMP release testing
—​​​​​​​ Residual Solvents testing
—​​​​​​​ Compendial Method Verification/Testing
—​​​​​​​ Impurity isolation and identification by Prep-LC,LC/MS, LC/MS/MS, NMR
—​​​​​​​ Stability Chambers
    · ICH stability storage and testing (25°C/60% RH; 30°C/65% RH;
      40°C/75% RH; 2-8 °C)
   · Photostability study
   · 24/7 alarms: email/online system

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