Physical properties screening...
In addition to screening options available at Solid Form Solutions, we offer a cGMP physical property and developability assessment on batches of API. Amongst the techniques available are:
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X-ray Powder Diffraction (XRPD)
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Single Crystal X-ray Diffraction
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Thermogravimetric Analysis (TA/DTA)
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Differential Scanning Calorimetry (DSC)
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Polarised Light Microscopy (PLM)
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Hot-Stage Microscopy (HSM)
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HPLC Analysis
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Metal Analysis
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Infra-red Spectroscopy (IR)
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Scanning Electron Microscopy (SEM)
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Storage Tests (To ICH Guidelines)
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Photostability (To ICH Guidelines)
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Dynamic Vapour Sorption (DVS)
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Nuclear Magnetic Resonance (1H, 13C, 2-D analysis)
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Counterion Analysis (i.e. chloride, ammonium analysis)
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Dissolution and Intrinsic Dissolution Testing (USP 2)
TGA Results:
An example of a TGA results trace (click to enlarge).
Would you like to know more?
If you have any questions regarding this or any of our service range please contact us.
