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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

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.
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

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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Articles

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.

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.

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.

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.

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