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Lactochem® Crystals

Highly consistent monohydrate lactose

Enhanced powder flow

Offerings from multiple production sites

Oral Solid Dose

Lactochem Crystals Monohydrate Lactose Excipient

Product information

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

Lactose is sieved to varying degrees of particle sizes allowing pharmaceutical companies to choose the grade best fitting their formulation needs. Pharmaceutical α-lactose monohydrate is sieved, contributing to formulations where flow is of key importance. This lactose type is typically used for sachets and capsule filling.

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

Typical product data

Particle size distribution (μm)

X10: 50
X50: 140
X90: 240

Bulk density (g/L)

Bulk density (g/L): 746

Hausner ratio (-)

Hausner ratio (-): 1.19

Documentation

ALBA Pharmaceutical lactose
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Oral Solid Dose Brochure View
GMO Statement lactose
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GMP+ DMV - Fonterra Excipients B.V. Borculo
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Halal DFE Pharma B.V. Borculo
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ICHQ3D Elemental Impurities Lactose EU and NZ
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Ingredient declaration lactose
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MSDS Anhydrous lactose
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MSDS Lactose monohydrate
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Product Specification Lactochem Crystals
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Process Flow Sheet (PFS) Sieved lactose
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Free from Foot and Mouth Disease lactose
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Viral safety statement lactose
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cGMP Statement
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BSE Statement Lactose & Inhalation
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Irradiation free
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Contaminants and residues lactose
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Dioxin statement lactose
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Data Integrity
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Genotoxic impurities
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Origin of Milk
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Absence of Melamine Lactose
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Residual solvent lactose
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Shelf life statement lactose
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