Pharmacopoeias’ and manufacturers’ requirements for the quality of hard gelatin capsule shells

INTRODUCTION. The lack of national requirements regulating the quality of empty hard gelatin capsule shells (before filling with medicines) causes difficulties not only for capsule developers and manufacturers but also for experts evaluating regulatory submissions. This necessitates a comparative an...

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Main Authors: E. L. Kovaleva, O. A. Matveeva, V. V. Shelestova, K. A. Balatskaya
Format: Artigo
Sprog:Russo
Udgivet: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2024-12-01
Serier:Регуляторные исследования и экспертиза лекарственных средств
Fag:
hard gelatin capsules
gelatin
excipients
dyes
preservatives
methods of analysis
pharmacopoeial requirements
Online adgang:https://www.vedomostincesmp.ru/jour/article/view/694
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