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Pharmatose® 350M

Monohydrat-Laktose mit hoher Konsistenz

Gute Verdichtungseigenschaften

Angebote von mehreren Produktionsstandorten

Orale feste Darreichungsformen

Produktinformation

Pharmatose® und Lactochem® sind die Markennamen von DFE Pharma für reine, weiße und hochkonsistente kristalline, gemahlene Laktosemonohydrate.

Laktose wird mechanisch zu unterschiedlichen Partikelgrößen gemahlen, so dass Pharmaunternehmen die Qualität wählen können, die am besten zu ihren Formulierungsanforderungen passt. Aufgrund ihrer feinen Beschaffenheit und relativ großen Oberfläche lässt sich gemahlene Laktose gut verdichten. Dieser Laktosetyp wird typischerweise in Tabletten, Kapseln und bei der Extrusionsspheronisierung verwendet.

: Gemahlene Laktose
Funktionalität des Hilfsstoffs: Füllstoff-Bindemittel, Verdünnungsmittel, Bindemittel
Empfohlenes Verfahren: Trockenes Mischen, Extrusionsspheronisation, Nassgranulation
Darreichungsformen: Tablette, Kapsel (orale Feststoffdosis)

Typische Produktdaten

Partikelgrößenverteilung (μm)

X10: 4
X50: 30
X90: 80

Rohdichte (g/L)

Rohdichte (g/L): 542

Hausner-Verhältnis (-)

Hausner-Verhältnis (-): 1.49

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
Inhaltsstoffdeklaration Laktose
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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 350M EU
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Prozessablaufplan (PFS) Gemahlene Laktose
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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

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