banner
Excipient

ICH-Q7 GMP Manufactured Product

Trehalose Dihydrate

USP, EP, JP, Ultra Low Endotoxin, GMP, Excipient Grade

Minimum Order Quantity: 25kg Lead Time: If Stock, 1-month / No Stock, 6-months
COAs Spec Sheet

Product Inquiry

Location of company
Self-use or resale *
If resale please fill out the following information
Intended application *
Intended end use *
Intended Use *
Application *
Package and Size *
Product Code: TRED-3252 | Previously: TE3252
Intended For Use As An Excipient In Biological Drug 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 non-reducing 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.

Product Specifications

NF COMPENDIA

ANALYSIS

SPECIFICATIONS

1Assay

  
 398.0% – 101.0%

Chloride and Sulfate, Chloride

  

≤ 0.0125%

Color and Clarity of Solution 

A720

A420-A720

≤ 0.033

≤ 0.067

2Endotoxins

  

 3≤ 0.3 EU/g

2Identification A

  

Conforms to Standard

2Identification B

  
Passes Test

2Identification C

  
Passes Test

2Microbial Content

Escherichia coli

Salmonella species

TAMC

TYMC

Absent/g

Absent/10g

≤ 50 CFU/g

≤ 20 CFU/g

2Nitrogen Determination

  

≤ 0.005%

2Optical Rotation, Specific Rotation @ 20°C

  

+197° to +201°

2pH @ 25°C
 

4.5 - 6.5

1Related Substances

Total Impurities with RRT <1.0

Total Impurities with RRT >1.0

≤ 0.5%

≤ 0.5%

2Residue on Ignition

  

≤ 0.1%

2Soluble Starch

  
Passes Test

Chloride and Sulfate, Sulfate

 

≤ 0.0200%

2Water Determination

 

9.0% to 11.0%
 

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

1Assay

  
 398.0% – 101.0%

Appearance of Solution

  

Clear, colorless

Chlorides

 

≤ 0.0125%

2Endotoxins

  

 3≤ 0.3 EU/g

2Identification A

  

Conforms to Standard

2Identification B

  
Passes Test

2Identification C

  
Passes Test

1Related Substances

Impurity A 

Impurity B

Unspecified Impurities

Total Impurities

≤ 0.5%

≤ 0.2%

≤ 0.2%

≤ 1.0%

2Microbial Content

Escherichia coli

Salmonella species

Staphylococcus aureus

Pseudomonas aeruginosa

TAMC

TYMC

Absent/g

Absent/10g

Absent

Absent

≤ 50 CFU/g

≤ 20 CFU/g

2pH @ 25°C

  

4.5 - 6.5

2Soluble Starch
 

Passes Test

2Specific Optical Rotation @ 20°C

  

+197° to +201°

Sulfated Ash

  

≤ 0.1%

Sulfates

  
≤ 0.0200%

2Water 

 

9.0% to 11.0%
 

JP COMPENDIA

ANALYSIS

SPECIFICATIONS

1Assay

  
 98.0% – 101.0%

Chloride

  

≤ 0.018%

2Dextrin, Soluble Starch, Sulfite 

 

Passes Test

Heavy Metals (as Pb)

  

≤ 5 ppm

2Identification 1

  

Passes Test

2Identification 2

  
Passes Test

2Identification 3

  

Conforms to Standard

2Nitrogen

  

≤ 0.005%

2Optical Rotation @ 20°C

  

+197° to +201°

2pH @ 25°C

  

4.5 – 6.5

2Residue on Ignition
 

≤ 0.1%

1Related Substances

Total Impurities with RRT <1.0

Total Impurities with RRT >1.0

≤ 0.5%

≤ 0.5%

Sulfate

  

≤ 0.0200%

2Water

  

9.0% to 11.0%
 

NON-COMPENDIAL ANALYSES

ANALYSIS

SPECIFICATIONS

Appearance and Color

  
 White to Off-White Crystalline Powder

1Residual Ethanol

  

≤ 200 ppm

1Residual Isopropyl Alcohol

 

≤ 250 ppm

1Residual Methanol

  

≤ 50 ppm

 

ANALYSIS

SPECIFICATIONS

Cadmium (Cd)

≤ 50 ppb

Arsenic (As)

  

≤ 50 ppb

Mercury (Hg)

  

≤ 50 ppb

Lead (Pb)

≤ 50 ppb

Nickel (Ni)

  

≤ 100 ppb

Molybdenum (Mo)

≤ 100 ppb

Copper (Cu)

≤ 100 ppb

Chromium (Cr)

≤ 100 ppb

Iron (Fe)

≤ 100 ppb

Aluminum (Al)

≤ 100 ppb

Zinc (Zn)

≤ 100 ppb

1Alternate Validated Method
2Analyses are Harmonized
3Specifications is more stringent than Compendia Monograph

Printable Version

General Product Description:

  • The Manufacturing of Trehalose, Dihydrate TRED-3252 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 TRED-3252 manufactured at BioSpectra and its raw materials 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 TRED-3252 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Trehalose Dihydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Trehalose, Dihydrate TRED-3252 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.

Tech Docs

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.

100 Majestic Way
Bangor, PA 18013 USA
610.599.3400

Site Map

Privacy Policy

Contact Us

Careers

© BioSpectra, Inc. All Rights Reserved.