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Excipient

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS)

USP, GMP, Excipient Grade

Minimum Order Quantity: 500kg Lead Time (if no stock): 3-months

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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.

CAS #: 77-86-1
Formula: C4H11NO3
Sol. In H2O @ 25°C (g/L): 550
F.W.: 121.14 g/mol
pH @ 20°C 5% aq.: 10.0 - 11.5
Useful pH: 7.0 - 9.0
pKa @ 20˚C: 8.3

Product Specifications

ANALYSIS SPECIFICATIONS
Absorbance (40%) 290 nm
≤ 0.2 a.u.
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
Identification B  
Passes Test
Identification C  
Passes Test
Identification (IR)  
Passes Test
Insoluble Matter  
≤ 0.005%
Karl Fischer Water  
≤ 2.0%
Loss on Drying  
≤ 1.0%
Melting Range  
168–172˚C

pH (5%)

  
10.0–11.5
Residue On Ignition  
≤ 0.1%
Trace Metals Arsenic (As)
Calcium (Ca)
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium(Mg)

≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
Printable Version

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.

Tech Docs
COAs
click to view
TRIS 0124 00161 TRIS 3220 TRIS 0124 00095 TRIS 3220 TRIS 0124 00074 TRIS 3220 TRIS 0124 00062 TRIS 3220 TRIS 0124 00061 TRIS 3220 TRIS 0124 00035 TRIS 3220 TRIS 0124 00015 TRIS 3220 TRIS 0123 00294 TRIS 3220 TRIS 0123 00213 TRIS 3220 50 TRIS 0123 00197 TRIS 3220 TRIS 0123 00173 TRIS 3220 TRIS 0123 00038 TRIS 3220 TRIS 0123 00028 TRIS 3220 TRIS 0123 00021 TRIS 3220 TRIS 0123 00016 TRIS 3220 TRIS 0123 00002 TRIS 3220 TRIS 0122 00157 TRIS 3220 TRIS 0122 00156 TRIS 3220 TRIS 0122 00155 TRIS 3220(2) TRIS 0122 00155 TRIS 3220 TRIS 0122 00150 TRIS 3220 TRIS 0122 00122 TRIS 3220 TRIS 0122 00119 TRIS 3220 TRIS 0122 00118 TRIS 3220 TRIS 0122 00117 TRIS 3220 TRIS 0122 00094 TRIS 3220 TRIS 0122 00093 TRIS 3220 TRIS 0122 00092 TRIS 3220 TRIS 0122 00088 TRIS 3220 TRIS 0122 00087 TRIS 3220 TRIS 0122 00086 TRIS 3220 TRIS 0122 00085 TRIS 3220 TRIS 0122 00084 TRIS 3220 TRIS 0122 00083 TRIS 3220 TRIS 0122 00061 TRIS 3220 TRIS 0122 00060 TRIS 3220 TRIS 0122 00059 TRIS 3220 TRIS 0121 00209 TRIS 3220 TRIS 0121 00205 TRIS 3220 TRIS 0121 00204 TRIS 3220 TRIS 0121 00203 TRIS 3220 TRIS 0121 00197 TRIS 3220 TRIS 0121 00196 TRIS 3220 TRIS 0121 00195 TRIS 3220 TRIS 0121 00167 TRIS 3220 TRIS 0121 00112 TRIS 3220 TRIS 0121 00110 TRIS 3220 TRIS 0121 00009 TRIS 3220 TRIS 0121 00008 TRIS 3220 TRIS 0121 00007 TRIS 3220 TR3220 015 1219 TR3220 015 0121 TR3220 014 1219 TR3220 013 1219 TR3220 012 0219 TR3220 011 0219 TR3220 010 0219 TR3220 009 0718 TR3220 008 0718 TR3220 007 0518 TR3220 006 0118 TR3220 005 1217

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.

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Bangor, PA 18013 USA
610.599.3400

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