Product Category


ICH-Q7 GMP Manufactured Product

Ch.P., GMP Excipient Grade

Product Code: TRIS-3251 | Previously: TR3251

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



Absorbance (40%) 290 nm
0.2 a.u. max.
Appearance and Color  
White / Crystals



≤ 1000 CFU/g

≤ 100 CFU/g

0.01% max.
Endotoxin Concentration  
≤ 30 EU/g




None Detected

None Detected

None Detected

Heavy Metals (Pb)  
5 ppm max.
Identification B  
Passes Test
Identification C
Passes Test
Identification (IR)  
Passes Test
Insoluble Matter  
0.005% max.
Karl Fischer Water 2% max.
Loss on Drying  
0.6% max.
Melting Range  
168 – 172 ºC

Bile tolerant Gram Neg. Bacteria

Escherichia coli

Pseudomonas aeruginosa

Staphylococcus aureus

Candida albicans

Salmonella sp

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 10g

pH (5%)  
10.0 – 11.5
Related Substances (TLC)  

1% max.

Residue on Ignition  
0.1% max
Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Nickel (Ni)

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

15 ppm max.

Printable Version

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General Product Description:

  • The manufacturing of Tromethamine TRIS-3251 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-3251 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, Chinese Pharmacopeia TRIS-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine, Chinese Pharmacopeia is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


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.

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.

Additional Packaging Information