Merck
All Photos(2)

1.12635

SAFC

Parteck® Delta M (Mannitol)

EMPROVE® ESSENTIAL, Ph. Eur., BP, 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

description

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

product line

EMPROVE® ESSENTIAL

form

fine powder

autoignition temp.

410 °C

potency

13500 mg/kg LD50, oral (Rat)

pH

5-7 (20 °C, 100 g/L in H2O)

bp

290-295 °C/4 hPa

mp

164-169 °C

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® Delta M excipient is a convertible mannitol specifically designed to handle wet granulation. Its delta-polymorphic crystals make it extremely adaptable. While it is monographed as a standard mannitol, this exceptional excipient changes its structure and converts into a beta-polymorph when it comes into contact with water. This creates a porous structure, thereby increasing the surface area, which leads to the ability to produce exceptionally hard tablets with fast disintegration.

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

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Certificate of Quality

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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.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
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