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Titre : | Quality Control and Manufacturing process of SEREXON â„¢ 160 mg at Salem laboratory |
Auteurs : | Amat errahmene Guermi, Auteur ; Nardjes Haroun, Auteur ; Imane Krache, Directeur de thèse |
Type de document : | document électronique |
Editeur : | Setif, Algerie : Faculté des sciences de la nature et de la vie, 2023 |
ISBN/ISSN/EAN : | MS/1706 |
Format : | 35 Feuilles |
Langues: | Français |
Catégories : | |
Mots-clés: | SEREXON™ 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 SEREXONâ„¢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 SEREXONâ„¢ 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 SEREXONâ„¢160 mg is considered of good pharmaceutical quality. |
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Code-barres | Cote | Support | Localisation | Section | Disponibilité |
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MS/1706 | BPM/CD6 | DVD et CD | Bibliothèque SNV | Français | Disponible |