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SuperTab® 30GR

An easy end-to-end DC solution

Hero underline
  • Agglomerated monohydrate lactose
  • Most compactable and flowable lactose monohydrate
  • Offers wide drug loading

SuperTab® 30GR

SuperTab® 30GR is a highly consistent, agglomerated monohydrate
lactose processed utilising a unique production technology. The granule
structure (containing small primary particle sizes), as a result of fluid
bed processing, provides optimal flow / compaction ratio allowing easy
direct compression processing. It is a product with ideal mixing
properties for low to high dose formulations and will contribute to an
efficient development process due to it is highly stable properties.

Specifications

Density

Tapped density 669 g/l
Bulk density 548 g/l

Particle size

D10 40 μm
D50 140 μm
D90 300 μm

Hausner ratio

1,22

Production site

Nörten Hardenberg, Germany

Sample size

Default 500 g

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

 

Optimal flow, compaction ratio

SuperTab® 30GR is the ideal starting material for Direct Compression formulations as it contributes to both flow and compaction.

Supports the process of formulation development

  • Highly stable
  • Low dwell time sensitivity
  • Low sensitivity to moisture
  • Low lubricant sensitivity

Excellent mixing properties and low segregation potential

Supporting content uniformity Employing an effective mixing plan for dispersing the API agglomerates using SuperTab® 30GR will enable successful formulation of low dose tablets during the tabletting process.

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 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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  • 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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  • 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) Granulated

    Process Flow Sheet (PFS) Granulated

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  • Process Flow Sheet (PFS) Granulated lactose

    Process Flow Sheet (PFS) Granulated lactose

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Product specifications

  • Product Specification SuperTab 30GR

    Product Specification SuperTab 30GR

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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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