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Property Assessment for Regulatory Filings

Several tests regarding material properties characterization are required for regulatory filings.  The tests are determined by the physical nature of the new drug substance and by its intended use.

At Crystal Pharmatech we offer:

Physicochemical properties determination:

     •     Solubility, pH of an aqueous solution.

     •     pH dependent solubility

     •     Melting point

     •     Log D and pKa Determination

     •     Forced degradation

Particle size measurement:

For some new drug substances intended for use in solid or suspension drug products, particle size can have a significant effect on dissolution rates, bioavailability, and / or stability.

Polymorphic forms assessment:

Some new drug substances exist in different crystalline forms which differ in their physical properties. Polymorphism may also include solvation or hydration products (also known as pseudopolymorphs) and amorphous forms. Differences in these forms could, in some cases, affect the quality or performance of the new drug products. In cases where differences exist which have been shown to affect drug product performance, bioavailability or stability, then the appropriate solid state should be specified.

Techniques used for form characterization are:

     •     X ray powder diffraction

     •     Thermal analysis procedures (DSC and TGA) for  melting point (including hot-stage microscopy),

     •     Solid state NMR.

     •     Raman and IR spectroscopy

          •     Optical microscopy