Merck
All Photos(1)

1.00419

SAFC

Parteck® M 200 (Mannitol)

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

Synonym(s):
Parteck Mannitol
Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
MDL number:
E Number:
E421
EC Index Number:
200-711-8

Quality Level

Agency

BP
ChP
JP
Ph. Eur.
USP

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

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

2-25°C

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2

InChI key

FBPFZTCFMRRESA-UHFFFAOYSA-N

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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. 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".

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

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

Enter Lot Number to search for Certificate of Quality (COQ).

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.

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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