Abstract
A new crystal form of 10-Propargyl-10-Deazaaminopterin, form SL, was discovered which is thermodynamically stable, shows long term stability and is applicable for using in final dosage forms. Form SL was characterized by several analytical methods such as thermal analysis by DSC, IR, X-ray powder diffraction, SEM (Scanning Electron Microscopy), Digital optical microscopy and solubility/dissolution measurements. Active pharmaceutical ingredients should be stable during technological processes for the preparation of a final dosage form and must also remain stable during storage. The morphology of long needle and plate shaped crystals was investigated by scanning electron microscopy (SEM) and optical microscopy. Form SL was compared to other forms of 10-Propargyl-10-Deazaaminopterin such as form A, B, C and to the amorphous form. The thermodynamic stability of form SL is supported by its long-term stability. Form SL is a pharmaceutically applicable crystal form.
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