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Merck

1.37096

SAFC

D-Mannitol

EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP

Pharma Manufacturing

Synonym(s):

Mannite

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About This Item

Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
Molecular Weight:
182.17
Beilstein:
1721898
MDL number:
UNSPSC Code:
12352201
EC Index Number:
200-711-8

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

product line

EMPROVE® EXPERT

form

solid

autoignition temp.

410 °C

pH

5-7 (20 °C, 100 g/L in H2O)

bp

290-295 °C/4 hPa

solubility

213 g/L

application(s)

liquid formulation
ophthalmics
parenterals
pharma/biopharma processes
pharmaceutical
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

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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This overview describes the challenges when developing parenteral formulations and strategies to overcome them and reduce the risk of production.

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