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Safety Information

1.02776

SAFC

Trehalose dihydrate

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

Pharma Manufacturing

Synonym(s):

D-(+)-Trehalose dihydrate, 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside, α,α-Trehalose, α-D-Glucopyranosyl-α-D-glucopyranoside

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About This Item

Empirical Formula (Hill Notation):
C12H22O11 · 2H2O
CAS Number:
Molecular Weight:
378.33
Beilstein:
5322018
MDL number:
UNSPSC Code:
12352201
EC Index Number:
202-739-6

Agency

ChP
JP
NF
Ph. Eur.

Quality Level

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1027761000BWT:
1027760000:
1027767777:
1027769013:
1027761000:


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

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

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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