Pharmatose® 450M

安定性の高い乳糖一水和物

良好な圧縮特性を有する

複数の生産拠点から供給

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に使用されます。

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）

代表的な製品データ

粒度分布(μm)

X10: 3
X10: 20
X90: 50

嵩密度(g/L)

嵩密度(g/L): 504

ハウスナー比 (-)

ハウスナー比 (-): 1.47

ドキュメンテーション

Oral Solid Dose Brochure
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Leaflet Oral Solid Dose - Milled Lactose 表示
Alba Pharmaceutical Lactose
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Contaminants Pharmatose, Respitose and Supertab (EU)
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FSSC 22000 FrieslandCampina DMV Veghel
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GMO Statement lactose 表示
Ingredient declaration lactose
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MSDS Lactose monohydrate
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Nutritional information lactose
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Residual solvent lactose
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Shelf life statement lactose
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Product Specification Pharmatose 450M
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Process Flow Sheet (PFS) Milled 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

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