Old_Chemistry Capabilities - PharmaBlock USA

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