SuperTab® 21AN

無水乳糖グレード

再圧縮が可能な高いコンパクタビリティ

水分に敏感な薬剤に最適

Oral Solid Dose

製品情報

SuperTab® 21ANは、安定性の高い無水乳糖です。その特徴的な構造は、主に無水β-乳糖の微結晶のクラスターを含んでいます。

無水乳糖であるため、水分含有量は低くなっています。この特性により、SuperTab® 21ANは、水分に敏感な原薬の製剤設計において一般的な選択肢となっています。ユニークで低レベルの結晶水により、PAT技術とSuperTab® 21ANを効率的に使用することができます。

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, カプセル剤（経口固形剤）

代表的な製品データ

粒度分布(μm)

X10: 15
X10: 170
X90: 340

嵩密度(g/L)

嵩密度(g/L): 722

ハウスナー比 (-)

ハウスナー比 (-): 1.25

ドキュメンテーション

ALBA Pharmaceutical lactose
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Oral Solid Dose Brochure 表示
Halal DFE Pharma Nörten-Hardenberg
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GMO Statement lactose
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GMP+ DMV-Fonterra Excipients Nörten-Hardenberg
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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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DFE Leaflet OSD Supertab 21AN 表示
Product Specification SuperTab 21AN
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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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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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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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