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Trehalose dihydrate

Trehalose dihydrate

Trehalose Dihydrate is a non-reducing disaccharide used as an excipient in biotherapeutic applications. Its primary purpose is to protect the protein drug substance both in the liquid and frozen state. It provides tonicity, stabilization, cryo-protection and lyo-protection. Trehalose is superior to other sugars due to the rigidity of the alpha 1,1 bond. Trehalose is also more stable under high temperature and acidic conditions. Due to its non-reducing end, Trehalose does not react with other excipients such as amino acids or aldehydes.

Trehalose is a white to off white crystalline powder
CAS #: 6138-23-4
Formula: C12H22O11 · 2H2O
Solubility in Water (g/L): 689
F.W.: 378.33 g/mol

EP Compendia - Product specifications


98.0 – 101.0%

Appearance of Solution

Clear, colorless


≤ 0.0125%


≤ 2.4 EU/g

Identification A

Conforms to Standard

Identification B

Passes Test

Identification C

Passes Test

Related Substances

Impurity A

Impurity B

Unspecified Impurities

Total Impurities

≤ 0.5%

≤ 0.5%

≤ 0.2%

≤ 1.0%

Microbial Content

Escherichia coli

Salmonella species





≤ 100 CFU/g

≤ 100 CFU/g

pH @ 25°C

4.5 – 6.5

Soluble Starch

Passes Test

Specific Optical Rotation @ 20°C

+197° to +201°

Sulfated Ash

≤ 0.1%


≤ 0.0200%


9.0% to 11.0%

Appearance and Color

White to Almost White Crystalline Powder

Residual Ethanol

≤ 5000 ppm

Residual Methanol

≤ 3000ppm

Different grades are available.

Regulatory information
Trehalose, Dihydrate is not manufactured with or using any of the following substances: Melamine, Latex and Glycerine.

The product and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.

The product and its raw materials are not subject to genetic modification.

Retest Date
The recommended retest period for Trehalose Dihydrate is based on current available stability data in accordance with the Stability Testing Program.

Storage and Shipping Conditions
Ship and Store in ambient conditions.
Store in a clean, dry and well-ventilated area.
Store in the original container.

Package Sizes
10kg and 25kg pails.