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1.00419

SAFC

Parteck® M 200 (Mannitol)

EMPROVE® ESSENTIAL, Ph. Eur., ChP, JP, USP, E 421

Pharma Manufacturing

Synonym(s):

D-Mannitol

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About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
69-65-8
Molecular Weight:
182.17
MDL number:
MFCD00064287
UNSPSC Code:
12352201
E Number:
E421
EC Index Number:
200-711-8

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

500

product line

EMPROVE® ESSENTIAL

form

fine powder

autoignition temp.

410 °C

quality

E 421

particle size

(see specification)

bp

290-295 °C/4 hPa

mp

164-169 °C

solubility

213 g/L

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General description

With formulation challenges in mind, we have used particle engineering technologies to develop functional excipients specifically for solid 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® M excipient achieves excellent compressibility while keeping the API stable throughout your manufacturing process and beyond. Based on directly compressible mannitol, it does not require further processing or high compression forces. The unique and large surface area of Parteck® M excipient enables rapid disintegration and quick release regardless of the dosage. It is well suitable for tableting processesusing direct compression or granulation techniques such as wet granulation androller compaction. Parteck® M is available in different particle sizes.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Features and Benefits

  • High compactibility at low compression forces
  • Rapid disintegration and fast dissolution
  • High dilution potential
  • Non-hygroscopic, exceptionally low content of reducing sugars
  • Uniform doses with homogenous distribution

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

  • Specification Sheet

    • What is the Emprove® Program?

    The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

    Material Qualification Dossier

    Free of charge - Sign in to download

    Quality Management Dossier

    Available by subscription or for a fee

    Operational Excellence Dossier

    Available by subscription or for a fee

    Learn more about the benefits an Emprove® Program subscription can provide
    Why are these documents unavailable?
    Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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