Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TREHALOSE Dihydrate
Ultra Low Endotoxin, EP, JP, NF, LBLE, GMP

Low Bioburden, Low Endotoxin, EP, JP, NF, GMP Manufactured Excipient Grade Product

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.

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

 
≤ 50 ppb

Arsenic

 

≤ 50 ppb

Mercury

 

≤ 50 ppb

Nickel

 

≤ 100 ppb

Molybdenum

 ≤ 100 ppb

Copper

 ≤ 100 ppb
Chromium  ≤ 100 ppb

Iron

 ≤ 100 ppb

Aluminum

 ≤ 100 ppb
Zinc  ≤ 100 ppb

 

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

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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.

Additional Packaging Information

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