SuperTab® 22AN

無水乳糖グレード

再圧縮が可能な高い圧縮性

高用量アプリケーションに最適

Oral Solid Dose

製品情報

SuperTab® 22ANは、無水乳糖の微粉末を低減し、流動性を向上させた製品です。特徴的な構造で、無水β-乳糖の微結晶のクラスターを含んでおり、低水分含量を実現しています。

SuperTab® 22ANは、良好な流動性とともに無水乳糖を必要とする高用量アプリケーション向けに開発されました。このタイプの乳糖は、一般的にローラー圧縮や直打に使用されます。

製品の種類: 製品の種類無水乳糖
添加剤の機能性: 充填剤・バインダー, 希釈剤, 結合剤
推奨プロセス: 直打法, 乾式造粒, 連続処理
剤形: 錠剤

代表的な製品データ

粒度分布(μm)

X10: 70
X10: 220
X90: 380

嵩密度(g/L)

嵩密度(g/L): 679

ハウスナー比 (-)

ハウスナー比 (-): 1.17

ドキュメンテーション

ALBA Pharmaceutical lactose
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Oral Solid Dose Brochure 表示
GMO Statement lactose
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GMP+ DMV-Fonterra Excipients Nörten-Hardenberg
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Halal DFE Pharma B.V. Borculo
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ICHQ3D Elemental Impurities Lactose EU and NZ
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Ingredient declaration lactose
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MSDS Anhydrous lactose
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MSDS Lactose monohydrate
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Product Specification SuperTab 22AN
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DFE Pharma OSD - Supertab 22AN Leaflet 表示

Process Flow Sheet (PFS) Anhydrous lactose
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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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BSE Statement Lactose & Inhalation
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Irradiation free
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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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Origin of Milk
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Absence of Melamine Lactose
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Residual solvent lactose
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Shelf life statement lactose
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Re-compaction properties of lactose and mcc 表示
Impact of excipient and blend properties on feeding consistency for continuous manufacturing 表示
Roller compaction of anhydrous lactose and mcc 表示

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