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Safety Information

1.02776

SAFC

Trehalose dihydrate

EMPROVE® EXPERT, Ph. Eur., ChP, NF, JP

Pharma Manufacturing

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Synonym(s):
D-(+)-Trehalose dihydrate, 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside, α,α-Trehalose, α-D-Glucopyranosyl-α-D-glucopyranoside
Empirical Formula (Hill Notation):
C12H22O11 · 2H2O
CAS Number:
6138-23-4
Molecular Weight:
378.33
Beilstein:
5322018
MDL number:
MFCD00071594
UNSPSC Code:
12352200
EC Index Number:
202-739-6

Agency

ChP
JP
NF
Ph. Eur.

Quality Level

500

product line

EMPROVE® EXPERT

form

solid

feature

RNase and DNase free

mp

96.5-97.5 °C

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
semi-solid formulation

storage temp.

no temp limit

SMILES string

[H]O[H].[H]O[H].OC[C@H]1O[C@H](O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@H](O)[C@@H](O)[C@@H]1O

InChI

1S/C12H22O11.2H2O/c13-1-3-5(15)7(17)9(19)11(21-3)23-12-10(20)8(18)6(16)4(2-14)22-12;;/h3-20H,1-2H2;2*1H2/t3-,4-,5-,6-,7+,8+,9-,10-,11-,12-;;/m1../s1

InChI key

DPVHGFAJLZWDOC-PVXXTIHASA-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

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.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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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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