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In dissolution testing

Despite the lack of inherent selectivity, it is still possible to obtain good quantitative data from online UV/vis monitoring by making use of chemometric techniques to resolve the overlapping spectra. The most common application is in dissolution testing [73, 74], where results that are at least as accurate as those of the reference (and much slower and more costly) HPLC method have been demonstrated. [Pg.252]

Used to determine the release of drugs from formulations with time, e.g. in dissolution testing. [Pg.75]

Volume Displacement. This parameter is not a factor in dissolution testing but can prove to be a very important factor in automated assay, content uniformity, or degradation and impurities testing. It specifically addresses the volume displaced by the tablets in solution. Since manual sample preparations are often prepared utilizing volumetric flasks where the solution is diluted to the mark, the actual volume of solvent added to the flask is irrelevant. However, this actual volume... [Pg.70]

Corrigan, O.l. (1991). Co-solvent systems in dissolution testing theoretical considerSiimip,Dev. Ind. [Pg.88]

Internal standards are often used in dissolution testing of oral dosage forms [42]. Internal standards should be avoided in stability-indicating assays due to the possible coelution with unknown degradation products. [Pg.270]

The difficulty in dissolution testing lies with analyzing very low concentrations of the dmg, even when the most well-established apparatus described in the... [Pg.37]

Reisman ME. 1999. Creating a stir in dissolution testing. Pharm. Formul. Qual. 2(6) 16-20... [Pg.263]

Bioequivalence and -avalibility can be assessed in vitro, for example in dissolution tests for controlled release forms, or in vivo in experimental animals in pharmacokinetic and/or pharmacodynamic studies. The results should be correlated with the pharmacological effects in the target organism. If the modified product is not bioequivalent or shows different therapeutic effects, clinical studies will be necessary. Products which have a narrow therapeutic ratio (e.g. a less than twofold difference between the minimum toxic and minimum effective concentration in the body 21 CFR 320) require clinical studies under all circumstances. [Pg.124]


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Dissolution testing

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