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SuperTab® 11SD

Hero underline
  • Spray dried lactose
  • Highly consistent dual sourced excipient
  • Offering excellent flow and compaction properties

SuperTab® 11SD

SuperTab® 11SD is a highly consistent, spray-dried monohydrate lactose enabling efficient tableting by offering free flow properties. It is developed to combine the high compactability of finely milled lactose with good flow properties of spherical spray-dried particles. Especially for low dose formulation SuperTab® 11SD is well suited to ensure content uniformity. This lactose type is typically used for tablet and capsule formulations.

Specifications

Density

Tapped density 716 g/l
Bulk density 599 g/l

Particle size

D10 50 μm
D50 120 μm
D90 220 μm

Hausner ratio

1,2

Production site

Nörten Hardenberg, Germany

Sample size

Default 500 g

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

Free flow properties

Enabling efficient processing.
SuperTab® 11SD exhibits good flow as demonstrated by multiple measurement techniques.

 

Stable content uniformity

Enabling very low dosed to medium dosed formulations. Due to its flowing character and surface morphology, excellent dispersability is achievable with SuperTab® 11SD. This phenomena enables tight content uniformity down to extreme, low dose levels.



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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MSDS

  • MSDS Lactose monohydrate

    MSDS Lactose monohydrate

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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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  • 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

    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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  • 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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  • 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) Spray-dried lactose

    Process Flow Sheet (PFS) Spray-dried lactose

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Product specifications

  • Product Specification SuperTab 11SD EU

    Product Specification SuperTab 11SD 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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