Trehalose Dihydrate Excipient LBLE

Excipient

ICH Q7 GMP Manufactured Product

Trehalose Dihydrate

EP, JP, ChP, NF, LBLE*, GMP, Excipient
Product Code: TRED-3250

*Low Bioburden, Low Endotoxin

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

Product Inquiry COAs Spec Sheet

Click the button above for additional pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: TRED-3250

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
Sol. In H₂O (g/L): 689
F.W.: 378.33 g/mol.
Solubility in H₂O: 50 g/L

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White to Almost White Crystalline Powder

Assay, Anhydrous Basis (NF/ChP/EP/JP)

98.0 – 101.0%

Appearance of Solution (EP)

Clear, Colorless

Chloride

Chloride (NF)

Chloride (ChP)

Chloride (EP)

Chloride (JP)

< = 125 ppm

< = 180 ppm

Color and Clarity of Solution (NF)

A720

A420 - A720

< = 0.033

< = 0.067

Dextrin, Soluble Starch, and Sulfite (JP)

Passes Test

Endotoxin (NF/ChP/EP)

< = 2.4 EU/g

Heavy Metals (Pb) (ChP)

< = 5 ppm

Identification, IR (NF-A/EP-A/JP-3/ChP-4)

Conforms to Reference Standard

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

Passes Test

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

Passes Test

Identification 3 (ChP)

Conforms to Reference Standard

Microbial Content
(NF/ChP/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/ChP/EP/JP)

+197° to +201°

pH (NF/EP/JP), Acidity (ChP)

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%

Related Substances (ChP)

< = 0.5%

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

< = 0.1%

Residual Solvents

Ethanol

Isopropyl Alcohol

Methanol

< = 200 ppm

< = 250 ppm

< = 50 ppm

Soluble Starch (NF/ChP/EP)

Passes Test

Sulfate

Sulfate (NF)

Sulfate (ChP)

Sulfate (EP)

Sulfate (JP)

< = 200 ppm

< = 240 ppm

Water, KF (NF/ChP/EP/JP)

9.0 - 11.0%

Printable Version

Key Product Features:

The manufacturing of Trehalose Dihydrate, TRED-3250 is performed at BioSpectra’s Bangor, PA facility
Appears as a white to almost 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.