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

Intended Use Statement


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

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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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.