Trehalose Dihydrate

Excipient

ICH Q7 GMP Manufactured Product

Trehalose Dihydrate

NF, EP, JP, Ultra Low Endotoxin, GMP, Excipient
Product Code: TRED-3252

Minimum Order Quantity: 25kg
Lead Time: 1-6 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: TRED-3252

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

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 nonreducing end, Trehalose does not react with other excipients such as amino acids or aldehydes.

CAS #: 6138-23-4
Formula: C₁₂H₂₂O₁₁•2H₂O
F.W.: 378.33 g/mol.
Solubility In H₂O: 50 g/L

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White to Off 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, Sulfite (JP)

Passes Test

Endotoxin (NF/EP)

< = 0.3 EU/g

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)

TAMC

TYMC

Escherichia coli

Salmonella species

Staphylococcus aureus

Pseudomonas aeruginosa

< = 50 CFU/g

< = 20 CFU/g

Absent/g

Absent/10g

Absent/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

Trace Metals

Cadmium (Cd)

Arsenic (As)

Mercury (Hg)

Lead (Pb)

Nickel (Ni)

Molybdenum (Mo)

Copper (Cu)

Chromium (Cr)

Iron (Fe)

Aluminum (Al)

Zinc (Zn)

< = 0.050 ppm

< = 0.100 ppm

Water, KF (NF/EP/JP)

9.0 - 11.0%

Printable Version

Key Product Features:

The manufacturing of Trehalose Dihydrate, TRED-3252 is performed at BioSpectra’s Bangor, PA facility.
Appears as white to off-white crystalline powder
Manufactured in accordance with ICH Q7
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 animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: α-D-Glucopyranosyl-α-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:

5kg, 10kg, 25kg, and 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.