Product Category

Excipient

ICH-Q7 GMP Manufactured Product

BIS-TRIS, LBLE, USP, EP,
GMP Excipient Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured

Product Code: BTRI-3250

Intended For Use As An Excipient


BIS-TRIS is a zwitterionic biological “Goods” buffer often used in biological pharmaceutical manufacturing and biochemistry for extraction, separation and purification, as well as an intermediate in synthetic reactions for both proteins and nucleic acid. BIS-TRIS is also used as a process aid in peptide synthesis. It can also be used as a scavenger agent for metal ions such as Cu and Pb.

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (0.1M)

280nm

340nm

≤ 0.04 a.u.

≤ 0.02 a.u.

Appearance and Color  

White Crystalline Powder

Assay (Titration, Dry Basis)

 

99.0% - 101.0%

Bioburden

≤ 100 CFU/g

Chloride

< 0.005%

Endotoxin

 ≤ 50 EU/g
Enzymes

DNase
Protease
RNase

None Detected
None Detected
None Detected

Heavy Metals (Pb)

 

≤ 3ppm

Identification (IR) (USP/EP)

 

Conforms to Reference Standard

Iron

 

≤ 3ppm

Loss on Drying (LOD)

 

≤ 1.0%

Melting Point

100 – 105°C 

pH (1% aqueous)

8.8 – 9.8 

pKa @ 25°C

6.3 – 6.7 

Residue on Ignition (ROI)

≤ 0.1%

Solubility 0.1M in H2O (USP)

 Clear + complete

Water (KF)

 ≤ 1.0%

Printable Version

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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formula-image
formula-image

BTRI-3250

CAS #: 6976-37-0

Formula: C8H19NO5

pH @ 25°C: 6.3 - 6.7
Melting Point/Range: 100 - 105°C

F.W.: 209.24 g/mol

General Product Description:

  • The manufacturing of BIS-TRIS, BTRI-3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.

  • BIS-TRIS is a White Crystalline product

  • Molecular Formula: C8H19NO5

  • Molecular Weight: 209.24 g/mol

  • CAS Number: 6976-37-0

  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

  • Biospectra certifies that all BIS-TRIS BTRI-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. BIS-TRIS manufactured at BioSpectra and any raw materials used in the manufacture of BIS-TRIS at BioSpectra are not subject to genetic modification.

  • Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2’’- nitrilotriethanol; Bis(2-hydroxyethyl) aminotris(hydroxymethyl)methane

 



GMP Compliance:

Bio Excipient Grade BIS-TRIS, BTRI-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of BIS-TRIS is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Residual Solvents Statement:

Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

Retest Date:

The recommended retest period for BIS-TRIS is two years from the date of manufacture.

Storage and Shipping Conditions:

Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.

Package Sizes:

10kg, 25 kg and 50 kg pails.

Additional Packaging Information

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