DFE Pharma - Lactochem® Fine Powder

製品情報

Pharmatose® および Lactochem® は、純白で非常に安定した結晶性の乳糖一水和物粉砕品のDFEファーマのブランド名です。

乳糖は機械的に様々な粒子径に粉砕されるため、製薬企業は製剤のニーズに最も適したグレードを選択することができます。乳糖は微細で、比較的高い表面積を持つため、よく圧縮されます。このタイプの乳糖は、通常、錠剤、カプセル、および押出スフェロニゼーションで使用されます。

製品の種類: 粉砕乳糖
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: 湿式造粒, 押出し球形化
剤形: 錠剤, カプセル剤（経口固形剤）, 分包品

代表的な製品データ

粒度分布(μm)

X10: 4
X10: 30
X90: 100

嵩密度(g/L)

嵩密度(g/L): 539

ハウスナー比 (-)

ハウスナー比 (-): 1.54

ドキュメンテーション

Leaflet Oral Solid Dose - Milled Lactose 表示
Oral Solid Dose Brochure 表示
ALBA Pharmaceutical lactose
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GMO Statement lactose
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GMP+ DMV - Fonterra Excipients B.V. Borculo
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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 Lactochem Fine Powder
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Process Flow Sheet (PFS) Milled 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

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