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Pharmatose® 450M

Hero underline
  • Highly consistent monohydrate lactose
  • Confer good compaction properties
  • Offerings from multiple production sites

Pharmatose® 450M

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.

Specifications

Density

Tapped density 742 g/l
Bulk density 504 g/l

Particle size

D10 3 μm
D50 20 μm
D90 50 μm

Hausner ratio

1,47

Production site

Veghel, the Netherlands 

Sample size

Default 500 g

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

A unique, wide portfolio supporting compaction

Find the milled lactose best fitting your formulation needs. DFE Pharma enables you to steer your granule hardness with different primary particle size. The smaller the primary particle size the higher the tablet hardness.

 

Document Overview

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).

Product specifications

  • Product Specification Pharmatose 450M

    Product Specification Pharmatose 450M

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Technical papers

Product sheets

Brochures

Process flow sheets

  • Process Flow Sheet (PFS) Milled lactose

    Process Flow Sheet (PFS) Milled lactose

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Contaminants

  • Contaminants Pharmatose, Respitose and SuperTab (EU)

    Contaminants Pharmatose, Respitose and SuperTab (EU)

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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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Ingredient Declaration

  • Ingredient declaration lactose

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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

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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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  • Free from Foot and Mouth Disease lactose

    Free from Foot and Mouth Disease lactose

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  • Irradiation free

    Irradiation free

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  • Latex free statement

    Latex free statement

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  • Non dangerous substance

    Non dangerous substance

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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

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  • World anti-doping code

    World anti-doping code

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  • Genotoxic Impurities

    409771 bytes

  • Non use of hormones

    1172897 bytes

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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ALBA

  • ALBA Pharmaceutical lactose

    ALBA Pharmaceutical lactose

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Proven track record

A confident choice:

- 100 years of experience

- Extensively researched in 750+ international, peer reviewed studies since 1990

- Studied with other DFE Pharma's functional excipients

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