Biospectra Logo
Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TREHALOSE Dihydrate, Ch.P., LBLE

Low Bioburden, Low Endotoxin, GMP Manufactured, Excipient Grade

Product Code: TRED-3251 | Previously: TE3251

minimum-quantity-image

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.

Product Specifications

ANALYSIS

SPECIFICATIONS (NF)
1Assay  
398.0% – 102.0%
Chloride and Sulfate, Chloride  
≤ 0.0125%
Color and Clarity of Solution  

A720 ≤ 0.050

A420 – A720 ≤ 0.100
2Endotoxins  
3≤ 2.4 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

≤ 100 CFU/g

≤ 100 CFU/g
Nitrogen Determination  
≤ 0.005%
2Optical Rotation, Specific Rotation @ 20°C +197° to +201°
2pH @ 25°C  
4.5 – 6.5
1Related Substances  
≤ 0.5%
2Residue on Ignition
 
≤ 0.1%
2Soluble Starch  
Passes Test
Chloride and Sulfate, Sulfate  
≤ 0.0200%
2Water Determination  
9.0 – 11.0%

 

 

ANALYSIS

SPECIFICATIONS (EP)
1Assay  
398.0% – 102.0%
Appearance of Solution  
Clear, colorless
Chlorides  
≤ 0.0125%
2Endotoxins  
3≤ 2.4 EU/g
2Identification A  
Conforms to Standard
2Identification B  
Passes Test
2Identification C  
Passes Test
1Related Substances

Impurities A and B

Unspecified Impurities

Total Impurities

≤ 0.5%

≤ 0.2%

≤ 1.0%
2Microbial Content

Escherichia coli

Salmonella species

TAMC

TYMC

Absent/g

Absent/10g

≤ 100 CFU/g

≤ 100 CFU/g
2pH @ 25°C  
4.5 – 6.5
2Soluble Starch  
Passes Test
2Specific Optical Rotation @ 20°C
 
+197º to +201º
Sulfated Ash  
≤ 0.1%
Sulfates  
≤ 0.0200%
2Water  
9.0% to 11.0%

 

 

ANALYSIS

SPECIFICATIONS (CP)
2 Acidity  
4.5 – 6.5
1 Assay  
98.0 – 102.0%
Color and Clarity of Solution  

A720 ≤ 0.033

A420 – A720 ≤ 0.067
Chloride  
≤ 0.0125%
2 Endotoxins  
3≤ 2.4 EU/g
Heavy Metals  
≤ 0.0005%
2Identification 1  
Passes Test
2Identification 2  
Passes Test
1Identification 3  
Passes Test
2Identification 4  
Conforms to Standard
2Microbial Content

Escherichia coli

Salmonella species

TAMC

TYMC

Absent/g

Absent/10g

3≤ 100 CFU/g

≤ 100 CFU/g
1Related Substances  
≤ 0.5%
2Residue on Ignition
 
≤ 0.1%
2Soluble Starch  
Passes Test
2Specific Optical Rotation @ 20°C
 
+197º to +201º
Sulfate  
≤0.020%
2Water

 
9.0 – 11.0%

Printable Version

 

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

List of C of As files
TRED-0123-00008_TRED-3251-92.pdf
TRED-0123-00007_TRED-3251.pdf
TRED-3251-92_TRED-0121-00011.pdf
TE3251-001-1220 (3).pdf
TE3251-002-1220 (3).pdf
TE3251-003-1220 (3).pdf
TE3251-001-1220 (2).pdf
TE3251-002-1220 (2).pdf
TE3251-003-1220 (2).pdf
TE3251-001-1220.pdf
TE3251-002-1220.pdf
TE3251-003-1220.pdf

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

minimum-quantity-image

COAs and Tech Docs

Product-image
formula-image

TRED-3251

CAS #: 6138-23-4

Formula: C12H22O11 • 2H2O

Sol. In H2O (g/L): 689

F.W.: 378.33 g/mol.

General Product Description:

  • The Manufacturing of Trehalose, Dihydrate TRED-3251 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-3251 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-3251 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-3251 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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging