Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS)
USP, GMP Excipient Grade

Product Code: TRIS-3220 | Previously: TR3220

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

ANALYSIS SPECIFICATIONS
Absorbance (40%) 290 nm
0.2 a.u. max.
Appearance and Color  
White / Crystals
Assay  
99.0–101.0%
Chloride ≤100 ppm
Enzymes

DNase

RNase

Protease

None Detected
None Detected
None Detected
Heavy Metals  
5 ppm max.
Identification B  
Passes Test
Identification C  
Passes Test
Identification (IR)  
Passes Test
Insoluble Matter  
0.005% max.
Karl Fischer Water  
2.0% max.
Loss on Drying  
1.0% max.
Melting Range  
168–172˚C

pH (5%)

 
10.0–11.5
Residue On Ignition  
0.1% max.
Trace Metals Arsenic (As)
Calcium (Ca)
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium(Mg)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
List of C of As files
TRIS-0124-00015_TRIS-3220.pdf
TRIS-0123-00294_TRIS-3220.pdf
TRIS-0123-00213_TRIS-3220-50.pdf
TRIS-0123-00197_TRIS-3220.pdf
TRIS-0123-00173_TRIS-3220.pdf
TRIS-0123-00038_TRIS-3220.pdf
TRIS-0123-00028_TRIS-3220.pdf
TRIS-0123-00021_TRIS-3220.pdf
TRIS-0123-00016_TRIS-3220.pdf
TRIS-0123-00002_TRIS-3220.pdf
TRIS-0122-00157_TRIS-3220.pdf
TRIS-0122-00156_TRIS-3220.pdf
TRIS-0122-00155_TRIS-3220(2).pdf
TRIS-0122-00155_TRIS-3220.pdf
TRIS-0122-00150_TRIS-3220.pdf
TRIS-0122-00122_TRIS-3220.pdf
TRIS-0122-00119_TRIS-3220.pdf
TRIS-0122-00118_TRIS-3220.pdf
TRIS-0122-00117_TRIS-3220.pdf
TRIS-0122-00094_TRIS-3220.pdf
TRIS-0122-00093_TRIS-3220.pdf
TRIS-0122-00092_TRIS-3220.pdf
TRIS-0122-00088_TRIS-3220.pdf
TRIS-0122-00087_TRIS-3220.pdf
TRIS-0122-00086_TRIS-3220.pdf
TRIS-0122-00085_TRIS-3220.pdf
TRIS-0122-00084_TRIS-3220.pdf
TRIS-0122-00083_TRIS-3220.pdf
TRIS-0122-00061_TRIS-3220.pdf
TRIS-0122-00060_TRIS-3220.pdf
TRIS-0122-00059_TRIS-3220.pdf
TRIS-0121-00209_TRIS-3220.pdf
TRIS-0121-00205_TRIS-3220.pdf
TRIS-0121-00204_TRIS-3220.pdf
TRIS-0121-00203_TRIS-3220.pdf
TRIS-0121-00197_TRIS-3220.pdf
TRIS-0121-00196_TRIS-3220.pdf
TRIS-0121-00195_TRIS-3220.pdf
TRIS-0121-00167_TRIS-3220.pdf
TRIS-0121-00112_TRIS-3220.pdf
TRIS-0121-00110_TRIS-3220.pdf
TRIS-0121-00009_TRIS-3220.pdf
TRIS-0121-00008_TRIS-3220.pdf
TRIS-0121-00007_TRIS-3220.pdf
TR3220-015-0121.pdf
TR3220-015-1219.pdf
TR3220-014-1219.pdf
TR3220-013-1219.pdf
TR3220-012-0219.pdf
TR3220-011-0219.pdf
TR3220-010-0219.pdf
TR3220-007-0518.pdf
TR3220-006-0118.pdf
TR3220-008-0718.pdf
TR3220-009-0718.pdf
TR3220-005-1217.pdf

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General Product Description:

  • The manufacturing of Tromethamine TRIS-3220 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-3220 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, Tri (Hydroxymethyl) Amino Methane.


GMP Compliance:

Bio Excipient Grade Tromethamine TRIS-3220 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.

Expiration:

The recommended expiration period for Tromethamine is three years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

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