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Pharmatose® 60M

Highly consistent monohydrate lactose

Enhanced powder flow

Offerings from multiple production sites

Oral Solid Dose

Pharmatose 60M Monohydrate Lactose Excipient

Product information

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.

Product types: Sieved lactose
Excipient functionality: Filler-binder, Diluent, Binder
Recommended process: Dry blending
Dosage forms: Capsule (Oral Solid Dose), Sachet

Typical product data

Particle size distribution (μm)

X10: 135
X50: 280
X90: 470

Bulk density (g/L)

Bulk density (g/L): 816

Hausner ratio (-)

Hausner ratio (-): 1.09

Documentation

ALBA Pharmaceutical lactose
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Oral Solid Dose Brochure View
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ICHQ3D Elemental Impurities Lactose EU and NZ
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Ingredient declaration lactose
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Product Specification Pharmatose 60M NZ
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Process Flow Sheet (PFS) Sieved lactose
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Absence of Melamine Lactose
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
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2. The document will open in Master Control, in a window of your browser. Click on Download>PDF
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4. Once the document is saved, open the file on your computer using Acrobat Reader (not your browser).
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Residual solvent lactose
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
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Shelf life statement lactose
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
1. Click on "Download document"
2. The document will open in Master Control, in a window of your browser. Click on Download>PDF
3. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
4. Once the document is saved, open the file on your computer using Acrobat Reader (not your browser).
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Re-compaction properties of lactose and mcc View

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