Pharmatose® 50M

安定性の高い乳糖一水和物

粉体流動性の向上

複数の生産拠点からの供給

Oral Solid Dose

製品情報

Pharmatose®およびLactochem®は、純白で非常に安定した結晶性の篩過乳糖一水和物グレードのDFEファーマのブランド名です。乳糖は様々な粒子径に篩過されるため、製薬企業は製剤のニーズに合わせて最適なグレードを選択することができます。製薬用α-乳糖一水和物は篩過されており、流動性が重要視される製剤に貢献します。このタイプの乳糖は、一般的に分包やカプセル充填に使用されます。

製品の種類: 篩過乳糖
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: ドライブレンド
剤形: 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: 235
X50: 360
X90: 490

嵩密度(g/L)

嵩密度(g/L): 719

ハウスナー比 (-)

ハウスナー比 (-): 1.11

ドキュメンテーション

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Oral Solid Dose Brochure
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Kontaminantenangabe Pharmatose, Respitose und SuperTab (EU)
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FSSC 22000 FrieslandCampina DMV Veghel
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Inhaltsstoffdeklaration Laktose
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Sicherheitsdatenblatt Lactose-Monohydrat
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Haltbarkeitsangabe Lactose
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Product Specification Pharmatose 50M EU
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Process Flow Sheet (PFS) Sieved lactose
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Process Flow Sheet (PFS) Sieved lactose
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GMP+ FrieslandCampina DMV B.V. Veghel 表示
ISO 14001 FrieslandCampina DMV Veghel 表示
ISO 9001 FrieslandCampina DMV Veghel 表示
ICHQ3D Elemental Impurities Lactose EU and NZ 表示
Free from Foot and Mouth Disease lactose 表示
World anti-doping code 表示
Non dangerous substance 表示
cGMP Statement 表示
BSE Statement Lactose & Inhalation 表示
Irradiation free 表示
Contaminants and residues lactose 表示
Change management 表示
Dioxin statement lactose 表示
Production site statement 表示
Data Integrity 表示
Certificate of suitability 表示
Latex free statement 表示
Genotoxic impurities 表示
Compliance packaging 表示
REACH statement 表示
Statement of business continuity planning 表示
Origin of Milk 表示
Absence of Melamine Lactose 表示

Re-compaction properties of lactose and mcc 表示