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Source text - French Concernant l’évaluation statistique des données de stabilité :
L’évaluation statistique des données de stabilité conduit à remettre en cause la durée de conservation de 2 ans actuellement accordée sur le produit fini sur la base des teneurs en principe actif et en impuretés de dégradation.
Cette évaluation statistique des données de stabilité appelle plusieurs remarques :
1. les conditions (température et humidité) de l’étude de stabilité qui est exploitée pour cette évaluation statistique ne sont pas précisées.
2. les méthodes utilisées pour le dosage du principe actif (par CLHP) et des impuretés de dégradation (par CCM) sont critiquables pour les raisons suivantes :
la méthode de dosage n’est pas démontrée comme « stability indicating » au sens de la note explicative ICH Q6A.
la méthode de dosage des impuretés de dégradation est obsolète en regard des exigences de la note explicative ICH Q3B.
En particulier, les limites de détection des impuretés sont pour la plupart supérieures au niveau du seuil de report lequel correspond au minimum à la limite de quantification qui n’a pas été établie) mentionné dans la note explicative ICH Q3B (0,1 % pour une dose maximale journalière de 1g en principe actif) :
Translation - English Regarding the statistical review of stability data:
The statistical review of stability data results in the questioning of the 2-year shelf life currently authorised for the finished product based on the active ingredient and degradation impurity content.
This statistical review of stability data compels several comments:
1. the conditions (temperature and humidity) of the stability study used for the purposes of this statistical review are not specified.
2. the methods used for the assay of the active ingredient (using HPLC) and degradation impurities (using TLC) are open to criticism for the following reasons:
the assay method is not proven to be “stability indicating” in the sense of guideline ICH Q6A.
the method for the assay of degradation impurities is obsolete in terms of the requirements of guideline ICH Q3B.
More particularly, the impurity detection limits are, for the most part,
above the reporting threshold that corresponds to the lowest limit of quantification (that has not been established)given in guideline ICH Q3B (0.1% for a maximum daily dose of 1g of active ingredient)
ITI-certified translator from French into English; editing (proofreading); alignment; transcribing of audio material.
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