Product Category


ICH-Q7 GMP Manufactured
Active Drug Substance


Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: TRIS-2255 | Previously: TR2255

Intended For Use As An Active Pharmaceutical Ingredient

Bio Active LBLE Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization.

Product Specifications

Absorbance (40%) 290 nm
≤ 0.2 a.u.
Appearance and Color White / Crystals
Assay 99.0-101.0%
Bacterial Endotoxins ≤ 3.0 EU/g
Enzymes RNase
None Detected
None Detected
None Detected
Heavy Metals (as Pb) ≤ 0.012 ppm
USP Identifications

A (IR)



Passes Test

Passes Test

Passes Test

Insoluble Matter ≤ 0.005%
Karl Fischer Water ≤ 2.0%
Loss on Drying ≤ 1.0%
Melting Range

168-172 ºC

Microbial Content

Escherichia coli

Pseudomonas aeruginosa


Staphylococcus aureus







≤ 100 CFU/g

≤ 10 CFU/g

Organic Impurities


Tris(hydroxymethyl)nitromethane (EP Related Impurity)



Any Unspecified Impurities

Total Impurities

NMT 1 ppm

NMT 1 ppm

NMT 1 ppm

NMT 15 ppm

NMT 300 ppm

NMT 300 ppm

pH (1 in 20)


 10.0 – 11.5

Residue on Ignition

≤ 0.1%

Residual Solvents



≤ 300 ppm

≤ 15 ppm

Trace Metals Aluminum (Al)
Calcium (Ca)
Iron (Fe)
Magnesium (Mg)
≤ 0.400 ppm
≤ 1 ppm
≤ 1 ppm
≤ 1 ppm
Elemental Impurities

Cadmium (Cd)

Lead (Pb)

Arsenic (As)

Mercury (Hg)

Cobalt (Co)

Vanadium (V)

Nickel (Ni)

Thallium (Tl)

Gold (Au)

Palladium (Pd)

Iridium (Ir)

Osmium (Os)

Rhodium (Rh)

Ruthenium (Ru)

Selenium (Se)

Silver (Ag)

Platinum (Pt)

Lithium (Li)

Antimony (Sb)

Barium (Ba)

Molybdenum (Mo)

Copper (Cu)

Tin (Sn)

Chromium (Cr)

≤ 0.005 ppm

≤ 0.012 ppm

≤ 0.036 ppm

≤ 0.007 ppm

≤ 0.012 ppm

≤ 0.024 ppm

≤ 0.079 ppm

≤ 0.019 ppm

≤ 0.238 ppm

≤ 0.024 ppm

≤ 0.024 ppm

≤ 0.024 ppm

≤ 0.024 ppm

≤ 0.024 ppm

≤ 0.191 ppm

≤ 0.024 ppm

≤ 0.024 ppm

≤ 0.595 ppm

≤ 0.214 ppm

≤ 1.667 ppm

≤ 3.572 ppm

≤ 0.714 ppm

≤ 1.429 ppm

≤ 2.619 ppm

Printable Version

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General Product Description:

  • The manufacturing of LBLE API Grade Tromethamine TRIS-2255 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of LBLE API Grade Tromethamine TRIS-2255 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • 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-2255 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:

LBLE API Grade Tromethamine TRIS-2255 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide.

Retest Date:

The recommended retest period for Tromethamine is two years from the date of manufacture.

Storage and Shipping Conditions:

  • Store in a clean and dry area.
  • Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information