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SuperTab® 21AN

Controlled, efficient processing

Hero underline
  • Anhydrous lactose grade
  • Highly compactable allowing re-compaction
  • Suitable for moisture sensitive drug

SuperTab® 21AN

SuperTab® 21AN is a highly consistent, anhydrous lactose. The characteristic structure contains clusters of microcrystals of predominantly anhydrous β-lactose. Due to being an anhydrous lactose it has a low moisture content. This property makes SuperTab® 21AN a popular choice in formulating with moisture sensitive API’s. The unique, low levels of crystalline water makes the use of SuperTab® 21AN with PAT technologies efficient.

Specifications

Density

Tapped density 906 g/l
Bulk density 722 g/l

Particle size

D10 15 μm
D50 170 μm
D90 340 μm

Hausner ratio

1,25

Production site

Nörten Hardenberg, Germany

Sample size

Default 500 g

Conforms to Ph. Eur., Lactose monograph / USP-NF, JP Anhydrous lactose monograph

 

Allows excellent compaction and re- compaction

Tablet crushing strength remains high after recompactability. Therefore SuperTab ® 21AN is the preferred choice for dry granulation processes.

 

Part of a portfolio offering enhanced functionality

DFE Pharma offers more anhydrous grades with different particle sizes and morphology to enable a best fit with your formulation requirements.

Suitable for moisture sensitive API

Exceptional low crystalline water amount. The unique, low levels of crystalline water makes the use of SuperTab® 21AN with PAT technologies efficient. Typically SuperTab® 21AN contains about 80% of the β-isomer.

Document Overview

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ALBA

  • ALBA Pharmaceutical lactose

    ALBA Pharmaceutical 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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MSDS

  • MSDS Anhydrous lactose

    MSDS Anhydrous 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

    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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Process flow sheets

  • Process Flow Sheet (PFS) Anhydrous lactose

    Process Flow Sheet (PFS) Anhydrous lactose

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Product specifications

  • Product Specification SuperTab 21AN

    Product Specification SuperTab 21AN

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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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