MilliporeSigma

1.12635

SAFC

Parteck® Delta M (Mannitol)

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

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

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

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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1 of 4

This Item
1.004191.004941.03668
Parteck® Delta M (Mannitol) EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, USP, E 421

SAFC

1.12635

Parteck® Delta M (Mannitol)

Parteck® M 200 (Mannitol) EMPROVE® ESSENTIAL, Ph. Eur., ChP, JP, USP, E 421

SAFC

1.00419

Parteck® M 200 (Mannitol)

Parteck® M 100 (Mannitol) EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, USP, E 421

SAFC

1.00494

Parteck® M 100 (Mannitol)

Parteck® M DPI EMPROVE® EXPERT, Ph. Eur., BP, JP, USP, E 421

SAFC

1.03668

Parteck® M DPI

form

fine powder

form

fine powder

form

fine powder

form

fine powder

mp

164-169 °C

mp

164-169 °C

mp

164-169 °C

mp

164-169 °C

storage temp.

2-25°C

storage temp.

2-25°C

storage temp.

2-25°C

storage temp.

2-25°C

Quality Level

500

Quality Level

500

Quality Level

500

Quality Level

500

agency

BP

agency

BP, ChP, JP, Ph. Eur., USP

agency

BP, ChP, JP, Ph. Eur., USP

agency

BP, JP, Ph. Eur., USP

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


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