Primellose®

クロスカルメロースナトリウム

水分吸収が速く、膨潤が早い

様々なプロセスで優れた崩壊性を発揮

Oral Solid Dose

製品情報

Primellose®は、DFEファーマのクロスカルメロースナトリウムの製品ブランド名です。オランダのFoxholにある専用の工場で製造されています。Primellose®は、様々な錠剤やカプセルに適しています。不溶性および水溶性充填剤との併用により、2%w/w～6%w/wの濃度で効果を発揮します。直接打錠、乾式・湿式造粒のいずれでも有効であり、粒内・粒外のいずれでも使用可能です。

その優れた性能から、湿式造粒、乾式造粒、直接打錠のいずれにおいても、ほぼ全ての原薬および添加剤との組み合わせで使用することができます。クロスカルメロースナトリウムの優れた機能性は、その優れたウィッキング能力によるものです

梱包形態

- 35Kgドラム、PEライナー付き

- サンプルサイズ：500g

品質保証期間

5年

生産地

オランダFoxhol

製品の種類: クロスカルメロースナトリウム
添加剤の機能性: 崩壊剤
推奨プロセス: 直打法, ドライブレンド, 乾式造粒, 湿式造粒
剤形: 錠剤, カプセル剤（経口固形剤）, 口腔内崩壊錠

代表的な製品データ

原料

原料: コットンセルロース

pH

pH: 6.6

崩壊メカニズム

崩壊メカニズム: 吸水・膨潤

ドキュメンテーション

ALBA Primellose
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Oral Solid Dose Brochure 表示
Contaminants statement Primellose
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ICHQ3D - Elemental Impurities Superdisintegrants
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Kosher DFE Foxhol
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Nutritional information Primellose
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GMO Statement Primellose
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Ingredient declaration Primellose
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MSDS Primellose
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DFE Leaflet OSD Primellose 表示
Product Specification Primellose
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Process flow sheet (PFS) Primellose®
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Free from Foot and Mouth Disease lactose
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Viral safety statement lactose
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cGMP Statement
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Irradiation free
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BSE Statement Superdisintegrants
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Contaminants and residues lactose
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Dioxin statement lactose
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Production site statement
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Data Integrity
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Certificate of suitability
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Latex free statement
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Genotoxic impurities
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Compliance packaging
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REACH statement
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Statement of business continuity planning
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Absence of Melamine Pharmacel, SuperStarch, Disintegrants
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Shelf life statement Primojel and Primellose
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Impact of excipient and blend properties on feeding consistency for continuous manufacturing 表示
Use of Primojel and Primellose in wet granulation 表示
Process flow sheet (PFS) Primellose®
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