Trehalose Dihydrate LBLE

BIO EXCIPIENT GRADE | TE3250

C of As and Tech Docs

INTENDED FOR USE AS AN EXCIPIENT IN BIOLOGICAL DRUG PRODUCTS

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BIO EXCIPIENT GRADE / TE3250

CAS #: 6138-23-4

Molecular Formula:

C12H22O11 • 2H2O

Solubility in Water (g/L): 689

F.W.: 378.33 g/mol.

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.


BioSpectra's Trehalose Dihydrate meets or exceeds EP/BP, JP and NF specifications.

 

ANALYSIS

SPECIFICATIONS
Appearance and Color  
White to Off-White Crystalline Powder
Appearance of Solution (EP)  
Clear, Colorless
Assay % w/w  
98.0% – 101.0%
Chloride

(NF)

(EP)

(JP) 

≤ 0.0125%

≤ 0.0125%

< 0.018%
Color and Clarity of Solution (NF)

A720

A420-A720

≤ 0.050

≤ 0.100 
Dextrin, Soluble Starch, Sulfite (JP)  
Passes Test
Endotoxins  
≤ 2.4 EU/g
Heavy Metals (as Pb)  
≤ 5 ppm
Identification A  
Conforms to Standard
Identification B  
Passes Test
Identification C
 
Passes Test
Identification 1 (JP) 
Passes Test
Identification 2 (JP) 
Passes Test
Identification 3 (JP) 
Passes Test
Impurities

Maltotriose (Impurity B)

Total Impurities with RRT <1.0

Total Impurities with RRT >1.0

Glucose (Impurity A)

Any other Impurities

Sum of Glucose, Maltotriose

and Other Impurities 

≤ 0.5%

≤ 0.5%

≤ 0.5%

≤ 0.5%

≤ 0.2%

≤ 1.0%

 
Microbial Content

Escherichia coli

Salmonella species

TAMC

TYMC

Absent

Absent

≤ 100 CFU/g

≤ 100 CFU/g
Nitrogen Content  
≤ 0.005%
pH @ 25°C

 
4.5 – 6.5
Residual Ethanol  

≤ 5000 ppm
Residual Isopropyl Alcohol  
≤ 5000 ppm
Residual Methanol  
≤ 3000 ppm
Residue on Ignition  
≤ 0.1%
Soluble Starch  
Passes Test
Specific Optical Rotation @ 20°C  
+197º to +201º
Sulfate

(NF)

(EP)

(JP) 

≤ 0.0200%

≤ 0.0200%

≤ 0.024%
Water (Karl Fischer)  
9.0% to 11.0%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
List of C of As files
TE3250-021-0820.pdf
TE3250-020-0820.pdf
TE3250-019-0820.pdf
TE3250-018-0820.pdf
TE3250-017-0720.pdf
TE3250-016-0720.pdf
TE3250-015-0720.pdf
TE3250-014-0720.pdf
TE3250-013-0720.pdf
TE3250-012-0420.pdf
TE3250-011-0320.pdf
TE3250-010-0320.pdf
TE3250-009-0320.pdf
TE3250-008-0220.pdf
TE3250-007-1219 G100.pdf
TE3250-006-1219 G100.pdf
TE3250-005-1219 G100.pdf
TE3250-004-1219.pdf
TE3250-003-1119.pdf
TE3250-002-1119.pdf
TE3250-001-1119.pdf

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The Manufacturing of Trehalose, Dihydrate TE3250 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 TE3250 manufactured at BioSpectra and its rawmaterials 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 TE3250 is manufactured in accordance with cGMP guidelines and is suitable to be used as an ICH Q7 Compliant cGMP Manufactured Excipient. This Grade of Trehalose, Dihydrate is suitable for use in Sterile or Injectable applications where terminal sterilization is required. It is not intended for use as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Expiration/Retest Date:

The recommended retest period for Trehalose, Dihydrate TE3250 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.