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D(-)-Mannitol EMPROVE® EXPERT Ph Eur,BP,USP,JP

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Description

Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low microbial and endotoxin limits which makes it especially suitable for high-risk applications.

In addition, it is supported by the Emprove® Program and documentation, helping to minimize regulatory and quality-associated risks in biopharmaceutical and pharmaceutical manufacturing.

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.

Additional information

Manufacturer

Merck KGaA

Quality

BP, JP, Ph.Eur., USP

Cas-No

69-65-8

Einecs

200-711-8

Dosage Form

biopharmaceutical formulations, parenteral formulations

Function

Bulking agent, lyoprotecting agent in lyophilization, stabilizer

Compendial Name

Mannitol

Documents and Links

SDS-D(-)-Mannitol EMPROVE® EXPERT Ph Eur,BP,USP,JP

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