GMP Biotech Product
TREHALOSE DIHYDRATE BIOTECH
USP, EP, JP, LBLE*, GMP
*Low Bioburden, Low Endotoxin
COAs Spec Sheet
Product Code: TRED-4250
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products
Trehalose Dihydrate is a high purity, GMP Reagent Grade, derived from plant not animal origins. 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.
Formula: C12H22O11 • 2H2O
F.W.: 378.33 g/mol
CAS #: 6138-23-4
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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98.0 -101.0% |
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≤ 0.0125% |
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≤ 0.050 ≤ 0.100 |
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≤ 2.4 EU/g | ||
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Conforms to Standard | ||
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Passes Test | ||
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Passes Test | ||
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Absent/g Absent/10g ≤ 100 CFU/g ≤ 100 CFU/g |
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≤ 0.005% |
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+197° to +201° |
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4.5 – 6.5 |
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≤0.5% ≤0.5% |
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≤ 0.1% | ||
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Passes Test |
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≤ 0.0200% |
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9.0% to 11.0% | ||
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Clear, Colorless | ||
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≤ 2.4 EU/g |
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Conforms to Standard |
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Passes Test |
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Passes Test |
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Absent/g Absent/g ≤ 100 CFU/g ≤ 100 CFU/g |
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4.5 – 6.5 |
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Absent/g Absent/10g ≤ 100 CFU/g ≤ 100 CFU/g |
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Passes Test |
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≤ 0.0200% |
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≤ 0.018% | ||
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Passes Test | ||
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≤ 5 ppm |
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Passes Test |
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Passes Test |
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Conforms to Standard |
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≤ 0.005% | ||
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+197° to +201° | ||
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≤ 0.5% ≤ 0.5% |
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≤ 0.024% |
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White to Almost White Crystalline Powder |
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≤ 200 ppm |
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≤ 250 ppm | ||
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≤ 50 ppm |
General Product Description:
Molecular Formula: C12H22O11 • 2H2O
Molecular Weight: 378.33 g/mol
CAS Number: 6138-23-4
Trehalose, Dihydrate Biotech:
- Trehalose is a white to off white crystalline powder
- Is manufactured under an ICH-Q7 Quality Managed cGMP System
- Manufactured in an enzyme free, hormone free and animal free environment
- Has no known major food allergens (as defined by FDA and WHO)
- The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
- Is not subject to genetic modification
- Synonyms: a-D-Glucopyranosy 1-a-D-glucopyranoside
Shelf Life Policy:
Three-year expiry from the date of manufacture.
Storage and Shipping Conditions:
Please refer to the SDS for storage and shipping conditions.
Package Size:
100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.