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Lyophilisation: difference between revisions

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142Residual moisture is measured by [[Karl Fischer titration]] or, less specifically, by [[Loss on drying|loss on drying]]. A discrepancy between the two on the same lot is informative: loss on drying substantially exceeding the Karl Fischer figure suggests [[Residual solvent|residual solvent]], whereas the reverse suggests water bound too tightly to be driven off at the drying temperature.142Residual moisture is measured by [[Karl Fischer titration]] or, less specifically, by [[Loss on drying|loss on drying]]. A discrepancy between the two on the same lot is informative: loss on drying substantially exceeding the Karl Fischer figure suggests [[Residual solvent|residual solvent]], whereas the reverse suggests water bound too tightly to be driven off at the drying temperature.
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+144Reconstitution time and clarity detect collapse, over-concentration and incipient aggregation. A cake that requires prolonged agitation, or that yields a hazy solution, is a documented indicator of physical instability even when chemical assay is within specification.{{r|wang2000}}
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144== References ==146== References ==
145{{reflist}}147{{reflist}}