Titre :	Quality Control and Manufacturing process of SEREXON â„¢ 160 mg at Salem laboratory
Type de document :	document électronique
Auteurs :	Amat errahmene Guermi, Auteur ; Nardjes Haroun, Auteur ; Imane Krache, Directeur de thèse
Editeur :	Faculté des sciences de la nature et de la vie
Année de publication :	2023
Importance :	35 Feuilles
ISBN/ISSN/EAN :	MS/1706
Langues :	Français
Catégories :	Thèse et mémoire:Master:Biotechnologie et pathologie moléculaire
Mots-clés :	SEREXONâ„¢ 160 mg  Saw palmetto  physicochemical controls  European pharmacopoeia9.8  USP-NF.
Résumé :	The pharmaceutical industry ensures the conformity and quality of pharmaceutical products to guarantee the therapeutic effect of its products. Our work focuses on quality control as well as the production process of SEREXON™160 mg, manufactured by Salem laboratory, El Eulma, Setif. This drug is based on a lipid-sterol extract of Serenoa repens which has shown remarkable efficacy in the treatment of benign prostatic hyperplasia. The aim of this study is to present the quality control procedures of Saw palmetto extract principal active ingredient of SEREXON™ 16 mg. Indeed, we conducted various physicochemical control analyses in order to establish the compliance of the drug with the standards described in the European Pharmacopoeia 9.8 and USP-NF. The results obtained infer the conformity of the extract of Saw palmetto (API), indicatingthis the generic drug SEREXON™160 mg is considered of good pharmaceutical quality.

Quality Control and Manufacturing process of SEREXON â„¢ 160 mg at Salem laboratory [document électronique] / Amat errahmene Guermi, Auteur ; Nardjes Haroun, Auteur ; Imane Krache, Directeur de thèse . - Setif, Algerie : Faculté des sciences de la nature et de la vie, 2023 . - 35 Feuilles.
ISSN : MS/1706
Langues : Français

Catégories :	Thèse et mémoire:Master:Biotechnologie et pathologie moléculaire
Mots-clés :	SEREXONâ„¢ 160 mg  Saw palmetto  physicochemical controls  European pharmacopoeia9.8  USP-NF.
Résumé :	The pharmaceutical industry ensures the conformity and quality of pharmaceutical products to guarantee the therapeutic effect of its products. Our work focuses on quality control as well as the production process of SEREXON™160 mg, manufactured by Salem laboratory, El Eulma, Setif. This drug is based on a lipid-sterol extract of Serenoa repens which has shown remarkable efficacy in the treatment of benign prostatic hyperplasia. The aim of this study is to present the quality control procedures of Saw palmetto extract principal active ingredient of SEREXON™ 16 mg. Indeed, we conducted various physicochemical control analyses in order to establish the compliance of the drug with the standards described in the European Pharmacopoeia 9.8 and USP-NF. The results obtained infer the conformity of the extract of Saw palmetto (API), indicatingthis the generic drug SEREXON™160 mg is considered of good pharmaceutical quality.