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Pharmatose® 50M

Hochgradig konsistente Monohydrat-Laktose

Verbesserter Pulverfluss

Erhältlich von mehreren Produktionsstandorten

Orale feste Darreichungsformen

Produktinformation

Pharmatose® und Lactochem® sind die Markennamen von DFE Pharma für reine, weiße und hochkonsistente kristalline, gesiebte Laktosemonohydrate. Die Laktose wird auf unterschiedliche Partikelgrößen gesiebt, so dass Pharmaunternehmen die Qualität wählen können, die am besten zu ihren Formulierungsanforderungen passt. Pharmazeutisches α-Laktosemonohydrat wird gesiebt und trägt zu Formulierungen bei, bei denen die Fließfähigkeit von entscheidender Bedeutung ist. Dieser Laktosetyp wird in der Regel für Sachets und Kapselfüllungen verwendet.

: Gesiebte Laktose
Funktionalität des Hilfsstoffs: Füllstoff-Bindemittel, Verdünnungsmittel, Bindemittel
Empfohlenes Verfahren: Trockenes Mischen
Darreichungsformen: Kapsel (orale Feststoffdosis), Sachet

Typische Produktdaten

Partikelgrößenverteilung (μm)

X10: 235
X50: 360
X90: 490

Rohdichte (g/L)

Rohdichte (g/L): 719

Hausner-Verhältnis (-)

Hausner-Verhältnis (-): 1.11

Dokumentation

Alba Pharmaceutical Lactose
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Oral Solid Dose Brochure
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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 Ansehen
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 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 Ansehen
ISO 14001 FrieslandCampina DMV Veghel Ansehen
ISO 9001 FrieslandCampina DMV Veghel Ansehen
ICHQ3D Elemental Impurities Lactose EU and NZ Ansehen
Free from Foot and Mouth Disease lactose Ansehen
World anti-doping code Ansehen
Non dangerous substance Ansehen
cGMP Statement Ansehen
BSE Statement Lactose & Inhalation Ansehen
Irradiation free Ansehen
Contaminants and residues lactose Ansehen
Change management Ansehen
Dioxin statement lactose Ansehen
Production site statement Ansehen
Data Integrity Ansehen
Certificate of suitability Ansehen
Latex free statement Ansehen
Genotoxic impurities Ansehen
Compliance packaging Ansehen
REACH statement Ansehen
Statement of business continuity planning Ansehen
Origin of Milk Ansehen
Absence of Melamine Lactose Ansehen

Re-compaction properties of lactose and mcc Ansehen