Trehalose Dihydrate LBLE
BIO EXCIPIENT GRADE | TE3250
INTENDED FOR USE AS AN EXCIPIENT IN BIOLOGICAL DRUG PRODUCTS
BIO EXCIPIENT GRADE / TE3250
CAS #: 6138-23-4
Molecular Formula:
C12H22O11 • 2H2O
Solubility in Water (g/L): 689
F.W.: 378.33 g/mol.
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.
BioSpectra's Trehalose Dihydrate meets or exceeds EP/BP, JP and NF specifications.
- Spec Sheet
- Compliance
- C of As
- SDS
- Quick Inquiry
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ANALYSIS |
SPECIFICATIONS |
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White to Off-White Crystalline Powder | |||
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Clear, Colorless | |||
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98.0% – 101.0% | |||
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≤ 0.0125% ≤ 0.0125% < 0.018% |
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≤ 0.050 ≤ 0.100 |
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Passes Test | |||
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≤ 2.4 EU/g | |||
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≤ 5 ppm | |||
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Conforms to Standard | |||
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Passes Test | |||
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Passes Test | |||
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Passes Test | |||
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Passes Test | |||
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Passes Test | |||
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≤ 0.5% ≤ 0.5% ≤ 0.5% ≤ 0.5% ≤ 0.2% ≤ 1.0%
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Absent Absent ≤ 100 CFU/g ≤ 100 CFU/g |
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≤ 0.005% | |||
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4.5 – 6.5 | |||
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≤ 5000 ppm |
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≤ 5000 ppm | |||
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≤ 3000 ppm | |||
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≤ 0.1% | |||
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Passes Test | |||
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+197º to +201º | |||
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≤ 0.0200% ≤ 0.0200% ≤ 0.024% |
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9.0% to 11.0% |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes |
General Product Description:
- The Manufacturing of Trehalose, Dihydrate TE3250 is performed at BioSpectra’s Bangor, PA facility
- Trehalose is a white to off white Crystalline powder
- Molecular Formula: C12H22O11 • 2H2O
- Molecular Weight: 378.33 g/mol
- CAS Number: 6138-23-4
- Trehalose, Dihydrate is not manufactured with or using any of the following substances: Melamine, Latex and Glycerine.
- BioSpectra certifies that all Trehalose, Dihydrate TE3250 manufactured at BioSpectra and its rawmaterials are not derived from or come in contact with animal parts, products, and/or byproducts.
- Trehalose, Dihydrate manufactured at BioSpectra and any raw materials used in the manufacture of Trehalose, Dihydrate at BioSpectra are not subject to genetic modification.
GMP Compliance:
Bio Excipient Grade Trehalose, Dihydrate TE3250 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured non-Sterile Excipient for use in further Manufacturing. This Grade of Trehalose, Dihydrate is not suitable to be used as a Sterile or Injectable Excipient, Active Pharmaceutical Ingredient, Drug Product or Household Item.
Expiration/Retest Date:
The recommended retest period for Trehalose, Dihydrate TE3250 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.