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Lactochem® Microfine

Hero underline
  • Highly consistent monohydrate lactose
  • Unique amount of extremly small particles
  • Enables to prevent segregation

Lactochem® Microfine

DFE Pharma is the only lactose supplier in the world that produces micronised lactose. Mircronised lactose has extremely small particles (90% is less than 10 micron). The product is used to create a pre-blend with the API to prevent segregation.

Specifications

Density

Tapped density 430 g/l
Bulk density 275 g/l

Particle size

D10 μm
D50 3 μm
D90 7 μm

Hausner ratio

1,56

Production site

Borculo, The Netherlands

Sample size

Default 500 g

Conforms to USP-NF, Ph.Eur., JP lactose monohydrate monograph

Document Overview

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ALBA

  • ALBA Pharmaceutical lactose

    ALBA Pharmaceutical lactose

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GMO

  • GMO Statement lactose

    GMO Statement lactose

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Halal certificates

Impurity statements

  • ICHQ3D Elemental Impurities Lactose EU and NZ

    ICHQ3D Elemental Impurities Lactose EU and NZ

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Nutritional

  • Nutritional information lactose

    Nutritional information lactose

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Other quality and regulatory documents

  • Absence of Melamine Lactose

    Absence of Melamine Lactose

    Because our PDF QAR documents are technically certified, you may experience difficulties when opening them in a browser. Save the PDF file first and then open the PDF file in a standard PDF reader (e.g. Adobe Reader).

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  • BSE Statement Lactose & Inhalation

    BSE Statement Lactose & Inhalation

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  • Certificate of suitability

    Certificate of suitability

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  • cGMP Statement

    cGMP Statement

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  • Change management

    Change management

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  • Compliance packaging

    Compliance packaging

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  • Contaminants and residues lactose

    Contaminants and residues lactose

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  • Data Integrity

    Data Integrity

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  • Dioxin statement lactose

    Dioxin statement lactose

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  • Irradiation free

    Irradiation free

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  • Latex free statement

    Latex free statement

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  • None metal catalyst statement

    None metal catalyst statement

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  • Origin of Milk

    Origin of Milk

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  • Production site statement

    Production site statement

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  • REACH statement

    REACH statement

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  • Statement of business continuity planning

    Statement of business continuity planning

    Because our PDF QAR documents are technically certified, you may experience difficulties when opening them in a browser. Save the PDF file first and then open the PDF file in a standard PDF reader (e.g. Adobe Reader).

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  • Viral safety statement lactose

    Viral safety statement lactose

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  • World anti-doping code

    World anti-doping code

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Product specifications

  • Product Specification Lactochem Microfine

    Product Specification Lactochem Microfine

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Residual solvent

  • Residual solvent lactose

    Residual solvent lactose

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Shelf life

  • Shelf life statement lactose

    Shelf life statement lactose

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Brochures

Technical papers

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