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SAFC

D-Mannitol

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

Pharma Manufacturing

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Synonym(s):
Mannite
Empirical Formula (Hill Notation):
C6H14O6
CAS Number:
69-65-8
Molecular Weight:
182.17
Beilstein:
1721898
MDL number:
MFCD00064287
UNSPSC Code:
12352200
EC Index Number:
200-711-8

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

500

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

mp

167-170 °C (lit.)

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

Application

Product No.
Description
Pricing

also commonly purchased with this product

Product No.
Description
Pricing

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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Articles

Overcoming Excipient Risks and Challenges for Parenteral Formulations

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

Use of Stabilizers and Surfactants to Prevent Protein Aggregation

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

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