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
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Assay
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98.0 – 101.0%
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Appearance of Solution
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Clear, colorless
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Chlorides
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≤ 0.0125%
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Endotoxins
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≤ 2.4 EU/g
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Identification A
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Conforms to Standard
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Identification B
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Passes Test
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Identification C
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Passes Test
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Related Substances
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Impurity A
Impurity B
Unspecified Impurities
Total Impurities
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≤ 0.5%
≤ 0.5%
≤ 0.2%
≤ 1.0%
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Microbial Content
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Escherichia coli
Salmonella species
TAMC
TYMC
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Absent/g
Absent/10g
≤ 100 CFU/g
≤ 100 CFU/g
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pH @ 25°C
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4.5 – 6.5
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Soluble Starch
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Passes Test
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Specific Optical Rotation @ 20°C
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+197° to +201°
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Sulfated Ash
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≤ 0.1%
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Sulfates
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≤ 0.0200%
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Water
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9.0% to 11.0%
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Appearance and Color
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White to Almost White Crystalline Powder
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Residual Ethanol
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≤ 5000 ppm
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Residual Methanol
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≤ 3000ppm
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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.