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Primojel®

Natrium-Stärkeglykolat Typ A

Außergewöhnliche Quellungseigenschaften gewährleisten einen schnellen Zerfall

Robuste Funktionalität in einer Vielzahl von Prozessen

Orale feste Darreichungsformen

Produktinformation

Primojel® Natriumstärkeglycolat ist ein Superzerfallsmittel, das für verschiedene Tabletten- und Kapselformulierungen geeignet ist. In höheren Konzentrationen kann Primojel® als auflösungsförderndes Mittel wirken. Primojel® ist hochwirksam, wenn es intragranular und/oder extragranular in Trocken-/Nassgranulationsverfahren eingesetzt wird.

Primojel® nimmt mehr als das 20-fache seines Eigengewichts an Wasser auf. Das schnelle Eindringen von Wasser in die Tabletten und die starke Quellung führen zu einem raschen Zerfall. Studien zeigen, dass Primojel® mehr Wasser aufnimmt als vergleichbare Produkte auf dem Markt und eine starke Zerfallskraft entwickelt, was es zu einem hochwirksamen Produkt macht.

Die pflanzliche Quelle, der Vernetzungsgrad und der Substitutionsgrad von Primojel® wurden optimiert, um eine schnelle Wasseraufnahme durch das Polymer zu ermöglichen, ohne dass sich ein zähflüssiges Gel bildet, das das Eindringen von Wasser in die Tablette behindern könnte. Die Beibehaltung der nativen kugelförmigen Struktur der Kartoffelstärkekörner unterstützt die optimalen Fließeigenschaften von Primojel®.

Verpackung

- 50-Kg-Fass mit PE-Folie

- Probengröße: 500g

Haltbarkeitsdauer

5 Jahre

Produktionsstandort

Foxhol, die Niederlande

: Natrium-Stärkeglykolat
Funktionalität des Hilfsstoffs: Zerfallsmittel
Empfohlenes Verfahren: Direkttablettierung, Trockengranulierung, Trockenes Mischen, Nassgranulation
Darreichungsformen: Tablette, Kapsel (orale Feststoffdosis), oral zerfallende Tablette

Typische Produktdaten

Quelle

Quelle: Kartoffelstärke

pH

pH: 6,7

Zersetzungsprozess

Zersetzungsprozess: Wickelung und Quellung

Dokumentation

ALBA Primojel
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Oral Solid Dose Brochure Ansehen
Kontaminanten-Erklärung Primojel
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GMO-Erklärung Primojel
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ICHQ3D - Elementare Verunreinigungen Zerfallsmitteln
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Koscher DFE Foxhol
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Sicherheitsdatenblatt Primojel
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Nährwertangaben Primojel
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Produktspezifikation Primojel
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DFE Pharma Leaflet OSD Primojel Ansehen

Prozessablaufplan (PFS) Primojel®
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Frei von Maul- und Klauenseuche Laktose
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Virale Sicherheitserklärung Lactose
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cGMP-Erklärung
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BSE-Erklärung Zerfallsmitteln
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Bestrahlungsfrei
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Erklärung zum Produktionsstandort
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Datenintegrität
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Eignungszertifikat
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Latexfrei-Erklärung
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Inhaltsstoffdeklaration Pharmacel sMCC
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Konformitätserklärung Verpackung
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REACH-Erklärung
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Erklärung zur Betriebskontinuitätsplanung
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Abwesenheit von Melamin Pharmacel, SuperStarch, Zerfallsmitteln
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Haltbarkeitsangabe Primojel und Primellose
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Impact of excipient and blend properties on feeding consistency for continuous manufacturing Ansehen
Use of Primojel and Primellose in wet granulation Ansehen

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