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Trehalose dihydrate EMPROVE® EXPERT Ph Eur,NF,JP

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Description

Trehalose is typically used in biopharmaceutical formulations as a stabilizer. Trehalose dihydrate Emprove® Expert features low microbial and endotoxin limits and a state-of-the art manufacturing process dedicated 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

Trehalose is widely used in biomolecule formulation as a stabilizing agent.
Trehalose dihydrate Emprove® Expert is low in endotoxins and bioburden, making it the right choice for your high-risk applications.

Additional information

Manufacturer

Merck KGaA

Quality

EP, JPE, USP-NF

Cas-No

6138-23-4

Einecs

202-739-6

Composition

trehalose

Dosage Form

biologics, biomolecule formulation, freeze drying, injectable, liquid formulation, mABs, Parenteral, protein formulation

Function

Cryoprotectant, Stabilizer for liquid biomolecule formulations

Documents and Links

SDS - Trehalose dihydrate EMPROVE® EXPERT Ph Eur,NF,JP

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