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Quality Assurance for PT-141 Every lot of PT-141 is released against an internal specification that combines reverse-phase HPLC for purity, ESI mass spectrometry for identity, Karl Fischer for residual moisture in the lyophilized cake, and visual inspection of vial integrity

Representative tissue specimens were embedded in paraffin, sectioned at 4 m, stained with hematoxylin and eosin (H&E), and evaluated by light microscopy using an Olympus 71 digital camera and an Olympus BX51 microscope (Japan) acquiring digital images saved as uncompressed 24-bit RGB TIFF files