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Pharmatose® 50M

Your proven, robust solution

Hero underline
  • Highly consistent monohydrate lactose
  • Enhanced powder flow
  • Offerings from multiple production sites

Pharmatose® 50M

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.

Specifications

Density

Tapped density 797 g/l
Bulk density 719 g/l

Particle size

D10 235 μm
D50 360 μm
D90 490 μm

Hausner ratio

1,11

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 flow

Find the sieved lactose best fitting your formulation needs.


A global offering supplied from multiple production locations

 

 

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).

ALBA

  • ALBA Pharmaceutical lactose

    ALBA Pharmaceutical 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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Contaminants

  • Contaminants Pharmatose, Respitose and SuperTab (EU)

    Contaminants Pharmatose, Respitose and SuperTab (EU)

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GMO

  • GMO Statement lactose

    GMO Statement 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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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

    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

    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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  • 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

    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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  • Data Integrity

    Data Integrity

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  • Dioxin statement lactose

    Dioxin statement 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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  • 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

    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

    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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  • World anti-doping code

    World anti-doping code

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Process flow sheets

  • Process Flow Sheet (PFS) Sieved lactose

    Process Flow Sheet (PFS) Sieved 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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Product specifications

  • Product Specification Pharmatose 50M EU

    Product Specification Pharmatose 50M EU

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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

Product sheets

Technical papers

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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