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Pharmatose® 350M NZ

Highly consistent monohydrate lactose

Confer good compaction properties

Offerings from multiple production sites

Oral Solid Dose

Pharmatose 350M Nz Monohydrate Lactose Excipient

Product information

Pharmatose® and Lactochem® are DFE Pharma’s brand names for pure white and highly consistent crystalline, milled lactose monohydrate grades.

Lactose is mechanically milled to varying degrees of particle sizes allowing pharmaceutical companies to choose the grade best fitting their formulation needs. Due to its fine nature and relatively high surface area, milled lactose compacts well. This lactose type is typically used in tablets, capsules and extrusion spheronisation.

Product types: Milled lactose
Excipient functionality: Filler-binder, Diluent, Binder
Recommended process: Dry blending, Extrusion spheronization
Dosage forms: Tablet, Capsule (Oral Solid Dose)

Typical product data

Particle size distribution (μm)

X10: 5
X50: 30
X90: 80

Bulk density (g/L)

Bulk density (g/L): 541

Hausner ratio (-)

Hausner ratio (-): 1.29

Documentation

Oral Solid Dose Brochure View
Leaflet Oral Solid Dose - Milled Lactose View
ALBA Pharmaceutical lactose
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Contaminants Pharmatose, Respitose and SuperTab (EU)
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ICHQ3D Elemental Impurities Lactose EU and NZ
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Ingredient declaration lactose
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Nutritional information lactose
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Product Specification Pharmatose 350 NZ
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Process Flow Sheet (PFS) Milled lactose
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Absence of Melamine Lactose
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
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Residual solvent lactose
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Shelf life statement lactose
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
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Re-compaction properties of lactose and mcc View

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