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References Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA

The pre-dissolved solution is by nature less stable than the lyophilisate, and after the first opening of the applicator the stability window shortens

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The guideline emphasizes that the impact of input material attributes and their variability on continuous processing and product quality should be assessed and proposed material attribute acceptable ranges should be justified. This means that for nanomaterials, relying solely on traditional chemical purity standards is far from sufficient

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