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1.37096

SAFC

D-Mannitol

EMPROVE® EXPERT Ph Eur,BP,USP,JP

Synonym(s):
Mannite
Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
Beilstein:
1721898
MDL number:
EC Index Number:
200-711-8

Quality Level

Agency/Method

BP
JP
Ph. Eur.
USP

product line

EMPROVE® EXPERT

autoignition temp.

410 °C

pH

5-7 (20 °C, 100 g/L in H2O)

bp

290-295 °C/4 hPa

mp

167-170 °C (lit.)

solubility

213 g/L

bulk density

400‑500 kg/m3

Featured Industry

Pharmaceutical
biopharma process and formulation
liquid formulation
ophthalmics
parenterals
semi-solid formulation
solid formulation

storage temp.

2-25°C

SMILES string

OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2/t3-,4-,5-,6-/m1/s1

InChI key

FBPFZTCFMRRESA-KVTDHHQDSA-N

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General description

Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process – for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules. Specifically developed for high-risk applications, they are low in bioburden and endotoxins.
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

Mannitol is a sugar alcohol which is used widely in biomolecule formulations as a stabilizer, bulking agent, and lyoprotecting agent, especially in lyophilization.
Due to its low microbial and endotoxin limits, D(-)-Mannitol Emprove® Expert is especially suitable for high-risk applications.

Biochem/physiol Actions

A sugar alcohol sweet tastant. Used in sweetness inhibition studies.

Legal Information

Emprove 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 Germany

WGK 1

Certificate of Analysis

Certificate of Origin

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?
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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