Trehalose Dihydrate Biotech, Plant Derived, NF, EP, JP, GMP

GMP Biotech Product

TREHALOSE DIHYDRATE BIOTECH

Plant Derived, NF, EP, JP, LBLE*, GMP
Product Code: TRED-4250

*Low Bioburden, Low Endotoxin

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Product Code: TRED-4250

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

Trehalose Dihydrate is a non-reducing disaccharide. Its primary purpose is to protect the protein drug substance, both in the liquid and frozen state. It provides tonicity, stabilization, cyroprotection and lyo-protection. Trehalose is superior to other sugars due to the rigidity of the alpha 1,1 bond and it is 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

ANALYSIS

SPECIFICATIONS

Appearance and Color

White to Almost White Crystalline Powder

Assay, Anhydrous Basis (NF/EP/JP)

98.0 - 101.0%

Appearance of Solution (EP)

Clear, colorless

Chloride

Chloride (NF)

Chloride (EP)

Chloride (JP)

< = 125 ppm

< = 180 ppm

Color and Clarity of Solution (NF)

A720

A420 – A720

< = 0.050

< = 0.100

Dextrin, soluble starch, and sulfite (JP)

Passes Test

Endotoxin (NF/EP)

< = 2.4 EU/g

Lead (Pb)

< = 5 ppm

Identification, IR (NF-A/EP-A/JP-3)

Conforms to Reference Standard

Identification B (NF-B/EP-B/JP-1)

Passes Test

Identification C (NF-C/EP-C/JP-2)

Passes Test

Microbial Content (NF/EP)

Escherichia coli

Salmonella species

TAMC

TYMC

Absent/g

Absent/10g

< = 100 CFU/g

Nitrogen (NF/JP)

< = 50 ppm

Specific Optical Rotation, 20°C (NF/EP/JP)

+197° to +201°

pH (NF/EP/JP)

4.5 – 6.5

Related Substances

Impurity A (EP)

Impurity B (EP)

Any Unspecified Impurities (EP)

Total Impurities (EP)

Total Impurities with RRT <1.0 (NF/JP)

Total Impurities with RRT >1.0 (NF/JP)

< = 0.5%

< = 0.2%

< = 1.0%

< = 0.5%

Residue on Ignition / Sulfated Ash (NF/EP/JP)

< = 0.1%

Residual Solvents

Ethanol

Isopropyl Alcohol

Methanol

< = 200 ppm

< = 250 ppm

< = 50 ppm

Soluble Starch (NF/EP)

Passes Test

Sulfate

Sulfate (NF)

Sulfate (EP)

Sulfate (JP)

< = 200 ppm

< = 240 ppm

Water, KF (NF/EP/JP)

9.0 - 11.0%

Printable Version

Key Product Features:

Appears as a white to almost white crystalline powder
Manufactured in accordance with IPEC
Manufactured in a hormone free and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and 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-Glucopyranosyl-a-D-glucopyranoside

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.