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SAFC

Parteck® M 100 (Mannitol)

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

Pharma Manufacturing

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Synonym(s):
D-Mannitol
Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
69-65-8
Molecular Weight:
182.17
MDL number:
MFCD00064287
UNSPSC Code:
12352107
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)

pH

5-7 (20 °C, 100 g/L in H2O)

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. 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.

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

WGK

WGK 1

Certificates of Analysis (COA)

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Articles

Use of Mannitol as an Excipient for Solid Drug Formulation

This article describes the advantages of mannitol when used as an excipient in solid drug formulation.

Dry Granulation in Solid Oral Formulation: Advantages of Spray-Dried Mannitol in Roll Compaction

In recent years, mannitol has gained popularity as an excipient in solid dosage formulation due to its beneficial physicochemical properties.

Tablet Manufacturing Technologies for Solid Drug Formulation

Learn about common tablet manufacturing technologies and the advantages and disadvantages of each.

Solid Formulation Development Using Melt-based 3D Printing Technologies

3D printing can overcome challenges during formulation development, with a focus on enhancing API bioavailability in solid dispersions. Find out how in this technical article.

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Pediatric Formulations

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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