Tromethamine (Tris) Free Flowing, LBLE

BIO EXCIPIENT GRADE | TR3252

INTENDED FOR USE AS AN EXCIPIENT

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formula-image

BIO EXCIPIENT GRADE / TR3252

CAS #: 77-86-1

Molecular Formula:

C4H11NO3

Solubility in Water @ 25°C (g/L): 550

F.W.: 121.14 g/mol

pH @ 20°C (5% aq. Soln.): 10.0 - 11.5

Useful pH: 7.0 - 9.0

pKa @ 20˚C: 8.3

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 

ANALYSIS

SPECIFICATIONS

USP COMPENDIA
Appearance and Color  
White/Crystals
Assay  
99.0 – 101.0%
Endotoxin  
≤2.5 EU/g
Identification A  
Passes Test
Identification B  
Passes Test
Identification C  
Passes Test
Loss on Drying  
≤1.0%
Melting Range  
168 - 172 ºC
pH (1 in 20)  
10.0 – 11.5
Residue on Ignition  
≤0.1%
Microbial Content

TAMC

TYMC

Total Bioburden

≤500 CFU/g

≤200 CFU/g

≤500 CFU/g

EP COMPENDIA
Appearance of Solution  
Passes Test
Assay  
99.0-100.5%
Chloride (Cl)  
≤100 ppm
Identification A  
Passes Test
Identification B  
168 - 174°C
Identification C  
Passes Test
Iron (Fe)  
≤10ppm
Loss on Drying at 105ºC  
≤0.5%
pH  
10.0 – 11.5
Related Substances  
≤1.0%
Sulfated Ash  
≤0.1%
Printable Version
List of C of As files
TR3252-001-0519.pdf

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General Product Description:

  • The manufacturing of Tromethamine TR3252 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • Tromethamine is a White Crystalline product
  • Molecular Formula: C4H11NO3
  • Molecular Weight: 121.14 g/mol.
  • CAS Number: 77-86-1
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Tromethamine TR3252 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Tromethamine manufactured at BioSpectra and any raw materials used in the manufacture of Tromethamine at BioSpectra are not subject to genetic modification.
  • Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane

 

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.

Free Flowing Material Statement:

This material was manufactured utilizing multiple proprietary purification, drying and packaging processes to increase the free-flowing nature of the product in the final package.  The final packaging configuration is also designed to help maintain those characteristics.

TruScan Statement:

Identification A (EP) is the alternate method for Identification by TruScan to confirm the identity of this product.

 

 



GMP Compliance:

Bio Excipient Grade Tromethamine, TR3252 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products including use in further manufacturing of parenteral grade products. This grade of Tromethamine is not sterile and requires terminal sterilization. It is not intended for use as an API, final Drug Product or Household item

Expiration/Retest Date::

The recommended retest period for Tromethamine 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, 25kg and 50kg pails.

 

Additional Packaging Information

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