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Quantitative analysis of bucillamine and its pharmaceutical formulation using FT-IR spectroscopy

Andrei A Bunaciu1, Hassan Y Aboul-Enein, Serban Fleschin

  • 1ROMSPECTRA IMPEX SRL, Analytical Research Department, 25 Street Maguricea, PO Box 52-3, Bucharest, Romania.

Farmaco (Societa Chimica Italiana : 1989)
|June 18, 2005
PubMed

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...