Home Available Excipients Pharmatose^® 200M

Pharmatose^® 200M

Lactose 200M

Pharmatose<sup>®</sup> 200M

Highly Consistent Monohydrate Lactose Delivers Good Compaction Properties Offerings From Multiple Production Sites

Specifications

Density	Tapped density	857 g/l
Density	Bulk density	589 g/l
Particle size	D10	5 μm
	D50	40 μm
	D90	120 μm
Hausner ratio	1,46
Production site	Veghel, the Netherlands
	Conforms to USP-NF, Ph.Eur., JP lactose monohydrate monograph

Quantity in kg

- +

Price per kg

$17.90

Size

Drum (50+) $17.90 / per kg Half pallet (250+) $10.30 / per kg Pallet (450) $7.65 / per kg

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Total

$895.00

Product variant

Expected delivery within 5-7 days. Each order ships with Certificate of Analysis, Material Safety Data Sheet and Product Data Sheet.

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.

Fast delivery

Halal and kosher certificates

Best Pharmaceutical grade lactose

Small quantities

Additional information

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. For more information on our other milled products, click here.

A global offering supplied from multiple production locations

Document Overview

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Product specifications

Product Specification Pharmatose 200M EU

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Technical papers

Re-compaction properties of lactose and mcc

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Wet granulation of milled lactose

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Product sheets

Product sheet Milled Lactose

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Brochure

Oral Solid Dose Brochure

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Process flow sheets

Process Flow Sheet (PFS) Milled lactose

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Process Flow Sheet Pharmatose 200M EU

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Contaminants

Contaminants Pharmatose, Respitose and SuperTab (EU)

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GMO

GMO Statement lactose

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Halal certificates

HALAL Veghel exp 31Oct2019

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Impurity statements

ICHQ3D Elemental Impurities Lactose EU and NZ

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Ingredient Declaration

Ingredient declaration lactose

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Nutritional

Nutritional information lactose

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Other quality and regulatory documents

Absence of Melamine Lactose

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BSE Statement Lactose & Inhalation

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Certificate of suitability

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cGMP Statement

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Change management

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Compliance packaging

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Contaminants and residues lactose

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Data Integrity

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Dioxin statement lactose

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Free from Foot and Mouth Disease lactose

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Irradiation free

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Latex free statement

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Non dangerous substance

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None metal catalyst statement

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Origin of Milk

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Production site statement

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REACH statement

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Statement of business continuity planning

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Viral safety statement lactose

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World anti-doping code

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Genotoxic Impurities

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Non use of hormones

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Residual solvent

Residual solvent lactose

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Shelf life

Shelf life statement lactose

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ALBA

ALBA Pharmaceutical lactose

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1 x $29.95

Subtotal

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