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Safety Information

1.04429

SAFC

Parteck® LM low

EMPROVE® ESSENTIAL

Pharma Manufacturing

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About This Item

UNSPSC Code:
12352107

grade

GMO free
GMP

Quality Level

500

description

granulated

product line

EMPROVE® ESSENTIAL

form

granular

particle size

80-220 μm (d50)

application(s)

pharmaceutical
solid formulation

storage temp.

2-25°C

General description

With formulation challenges in mind, we have used particle engineering technologies to develop functional excipients specifically for solid oral dosage forms. The products in our Parteck® portfolio feature unique particle properties tailored for excellent performance in tableting processes, for specific drug delivery technologies, or for solubility enhancement.

As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Parteck® LM excipient comes with three functions: filler, binder, and lubricant for solid dose formulation. It shows excellent flow properties and allows consistent dosing and robust, constant mixing times in batch and continuous manufacturing processes. It is very well suited for all classical solid dose formulation techniques such as direct compression, roller compaction, dry granulation as well as capsule filling.
Two grades are available: Parteck® LM low for low dose applications and less requirement for lubrication. Parteck® LM high for higher API loads and more demanding cases with regards to lubrication.

Features and Benefits

  • Multifunctional excipient for compression tableting processes – Filler + binder + lubricant
  • Reduces dosing issues in continuous manufacturing
  • Handling robustness supports limitation of overlubrication in batch operation
  • High binding capacity = strong tablets
  • Proven lubrication efficiency
  • Two grades allow for flexibility in formulation development

Packaging

1.04429.1000 / 1 kg / PE bottle
1.04429.9025 / 25 kg / PE bag (in carton)

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
PARTECK is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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