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ScienceRise: Pharmaceutical Science
Article . 2020 . Peer-reviewed
Data sources: Crossref
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ScienceRise: Pharmaceutical Science
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Development of an advanced strategy on the assay method transfer

Authors: Volovyk, Natalia; Leontiev, Dmytro; Petrus, Vasyl; Gryzodub, Oleksandr; Pidpruzhnykov, Yurii;

Development of an advanced strategy on the assay method transfer

Abstract

Aim . The paper intends to frame and pilot the optimised science-based principles of the assay transfer. Materials and methods . The research was performed on desloratadine film-coated tablets, using an analytical balance Mettler Toledo XP 205DR and Class A volumetric glassware. Absorbance readings were measured on a UV-Vis spectrophotometer Lambda 25. Results and discussion . The concept of method transfer that complements the conventional approach to validation with the lifecycle initiative and the metrological base of the State Pharmacopoeia of Ukraine was substantiated, following which the transfer of the spectrophotometric procedure for desloratadine assay was conducted. For the batch intended for the transfer, the budget of analytical and technological variability was balanced. The deviation of a single assay result from the grand mean was used as the criterion for accuracy in the transfer. The requirement for the one-sided confidence interval for assay result runs not to exceed the target uncertainty of the procedure was used as the criterion for precision. The control strategy requirements for variability sources and the analytical target profile requirements for precision and accuracy were met in the receiving unit. Conclusion . The paper discusses the premise and advocates an alternative approach to the method transfer. Precision is proposed not to study during the transfer (in the short-term experiment) but assess from the stability data (in the long-term experiment). Compliance with the normal analytical practice (the maximum permissible variability attributed to analysts and analytical instruments) allows narrowing down the transfer design to the confirmation in the minimal experiment that the amplitude of variability sources lies within the predefined range

Keywords

analytical procedure transfer; lifecycle; acceptance criteria; measurement uncertainty; desloratadine tablets, UDC 615.072: 543.42.062, трансфер аналітичних методик; життєвий цикл; критерії прийнятності; невизначеність вимірювань; таблетки дезлоратадину, трансфер аналитических методик; жизненный цикл; критерии приемлемости; неопределенность измерений; таблетки дезлоратадина

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selected citations
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This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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