Product Category


ICH-Q7 GMP Manufactured Product

USP, EP, LBLE (Standard)
GMP Excipient Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured

Product Code: TRIS-3254 | Previously: TR3254

Intended For Use As An Excipient

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.

Product Specifications



Appearance and Color  
99.0 – 101.0%
≤ 2.5 EU/g
Identification A


Passes Test

Identification B  

Passes Test

Identification C  
Passes Test
Loss on Drying  
≤ 1.0%
Melting Range


168 - 172ºC

pH (1 in 20)  
10.0 – 11.5
Residue on Ignition  
≤ 0.1%
Microbial Content



≤ 500 CFU/g

≤ 200 CFU/g




Appearance of Solution  
Passes Test
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  


10.0 – 11.5
Related Substances


≤ 1.0%

Sulfated Ash  

≤ 0.1%

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General Product Description:

  • The manufacturing of Tromethamine TRIS-3254 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 TRIS-3254 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


GMP Compliance:

Bio Excipient Grade Tromethamine TRIS-3254 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine 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.


The recommended expiration period for Tromethamine is three 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