TREHALOSE DIHYDRATE BIOTECH

GMP Biotech Product

TREHALOSE DIHYDRATE BIOTECH

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

*Low Bioburden, Low Endotoxin

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Price per unit (USD)		Price per kilogram (USD)
1kg	2-5kg (1kg ea)	1x5kg	1x10kg
$415 ea.	$395 ea.	$375 /kg	$355 /kg

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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

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

General Product Description:

Molecular Formula: C₁₂H₂₂O₁₁•2H₂O
Molecular Weight: 378.33 g/mol
CAS Number: 6138-23-4
Appears as a white to almost white crystalline powder
Manufactured in accordance with IPEC
Manufactured in a 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:

Unless otherwise noted on the shelf-life statement and CoA, this product has a retest date 2-years from the date of manufacture, supported by an ICH Q7 Stability Study (if one is completed).

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

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.