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Buffer / Excipient

ICH-Q7 GMP Manufactured Product

Tris Excipient

USP, EP, JP, LBLE*, GMP, Excipient Grade

*Low Bioburden, Low Endotoxin

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

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Product Code: TRIS-3255 | Previously: TR3255
Intended For Use As An Excipient

Tromethamine (TRIS BASE), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. TRIS BASE 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 (USP)
Assay (dried basis)  
99.0-101.0%
Identification A  
Passes Test
Identification B  
Passes Test
Identification C
 
Passes Test
Loss on Drying  
1.0% max.
Melting Range  
168-172oC
pH (1 in 20)  
10.0-11.5
Residue on Ignition  
0.1% max.

 

ANALYSIS

SPECIFICATIONS (EP)
Appearance of Solution  
Passes Test
Assay (dried basis)  
99.0-100.5%
Chloride (Cl)  
≤ 100ppm
Identification A  
Passes Test
Identification B (Melting Range)  
168-172°C
Identification C  
Passes Test
Identification D  
Passes Test
Iron (Fe)  
10ppm max.
Loss on Drying @ 105°C  
0.5% max.
pH (5%)  
10.0-11.5
Related Substances  
≤ 1.0%
Sulfated Ash  
0.1% max.

 

ANALYSIS

SPECIFICATIONS (JPC)
Arsenic (As)  
1.6 ppm max.
Assay (dried basis)  
99.0-101.0%
Clarity and Color of Solution  
Passes Test
Heavy Metals
 
8 ppm max.
Identification A
 
Passes Test
Identification B  
Passes Test
Loss on Drying  
0.5% max.
Melting Point  
168-172oC
pH  
10.3-10.7
Residue on Ignition  
0.1% max.

 

ANALYSIS

SPECIFICATIONS (Other)
Absorbance (1M)

260nm

280nm

430nm

0.06 a.u. max.

0.06 a.u. max.

0.01 a.u. max.
Absorbance (10%)

260nm

280nm

430nm

0.03 a.u. max.

0.02 a.u. max.

0.004 a.u. max.
Absorbance (40%)

290nm

0.2 a.u. max.
Appearance and Color

White, crystalline powder to needle-like crystals
APHA Color, 20% Solution  

20 APHA max.
Assay (dried basis)  

99.9% min
Endotoxins  

≤ 2.5 EU/g
Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected
Heavy Metals (as Pb)  

1ppm max.
Insoluble Matter  

0.005% max.
Karl Fischer Water  

1.0% max.
Loss on Drying  

0.3% max.
Microbial Content

TAMC

TYMC

≤ 100 CFU/g

≤ 100 CFU/g
Related Substances  

0.1% max.
Residue on Ignition  

0.05% max.
Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)
Zinc (Zn)

< 1.6 ppm
< 1 ppm
< 1 ppm
< 1 ppm
< 1 ppm
< 5 ppm
< 1 ppm
< 1 ppm

 

Printable Version

General Product Description:

  • The manufacturing of Tromethamine TRIS BASE TRIS-3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • TRIS BASE 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 TRIS BASE TRIS-3255 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. TRIS BASE manufactured at BioSpectra and any raw materials used in the manufacture of TRIS BASE at BioSpectra are not subject to genetic modification.
  • Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane, TRIS BASE

Product Statements:

Plant or Animal Origin Statement: BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, is not derived from Plant or Animal Origin.

Metal Residue Statement: BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.

Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code
TRIS-3255, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.

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.

GMP Compliance:

Bio Excipient Grade Tromethamine (TRIS BASE) Multicompendial TRIS-3255 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine (TRIS BASE) Multicompendial 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:

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:

10 kg and 25 kg pails and 50 kg drums

Tech Docs
COAs
click to view
TRIS 0124 00160 TRIS 3255 TRIS 0124 00158 TRIS 3255 TRIS 0124 00155 TRIS 3255 TRIS 0124 00157 TRIS 3255 10 TRIS 0124 00140 TRIS 3255 TRIS 0124 00139 TRIS 3255 TRIS 0124 00136 TRIS 3255 TRIS 0124 00124 TRIS 3255 TRIS 0124 00072 TRIS 3255 TRIS 0124 00073 TRIS 3255 TRIS 0124 00069 TRIS 3255 TRIS 0124 00071 TRIS 3255 TRIS 0222 00159 TRIS 3255 TRIS 0222 00048 TRIS 3255 TRIS 0124 00065 TRIS 3255 TRIS 0124 00064 TRIS 3255 TRIS 0124 00054 TRIS 3255 TRIS 0124 00050 TRIS 3255 TRIS 0124 00046 TRIS 3255 TRIS 0124 00045 TRIS 3255 TRIS 0124 00044 TRIS 3255 TRIS 0124 00032 TRIS 3255 TRIS 0124 00030 TRIS 3255 TRIS 0124 00027 TRIS 3255 TRIS 0124 00025 TRIS 3255 TRIS 0124 00022 TRIS 3255 TRIS 0123 00297 TRIS 3255 TRIS 0123 00271 TRIS 3255 TRIS 0123 00270 TRIS 3255 TRIS 0123 00267 TRIS 3255 TRIS 0123 00259 TRIS 3255 TRIS 0123 00240 TRIS 3255 TRIS 0123 00239 TRIS 3255 TRIS 0123 00214 TRIS 3255 TRIS 0123 00200 TRIS 3255 TRIS 0123 00199 TRIS 3255 TRIS 0123 00198 TRIS 3255 TRIS 0123 00177 TRIS 3255 TRIS 0123 00176 TRIS 3255 TRIS 0123 00174 TRIS 3255 TRIS 0123 00156 TRIS 3255 TRIS 0123 00155 TRIS 3255 TRIS 0123 00154 TRIS 3255 TRIS 0123 00153 TRIS 3255 TRIS 0123 00129 TRIS 3255 92 TRIS 0123 00128 TRIS 3255 92 TRIS 0123 00127 TRIS 3255 92 TRIS 0123 00115 TRIS 3255 TRIS 0123 00114 TRIS 3255 TRIS 0123 00108 TRIS 3255 TRIS 0123 00107 TRIS 3255 TRIS 0123 00106 TRIS 3255 TRIS 0123 00048 TRIS 3255 TRIS 0123 00025 TRIS 3255 TRIS 0123 00024 TRIS 3255 TRIS 0123 00012 TRIS 3255 TRIS 0123 00011 TRIS 3255 TRIS 0123 00010 TRIS 3255 TRIS 0123 00009 TRIS 3255 TRIS 0123 00008 TRIS 3255 TRIS 0122 00193 TRIS 3255 TRIS 0122 00187 TRIS 3255 TRIS 0122 00179 TRIS 3255 TRIS 0122 00177 TRIS 3255 TRIS 0122 00174 TRIS 3255 TRIS 0122 00173 TRIS 3255 TRIS 0122 00163 TRIS 3255 TRIS 0122 00161 TRIS 3255 TRIS 0122 00154 TRIS 3255 TRIS 0122 00149 TRIS 3255 TRIS 0122 00142 TRIS 3255 TRIS 0122 00139 TRIS 3255 TRIS 0122 00127 TRIS 3255 TRIS 0122 00124 TRIS 3255 TRIS 0122 00123 TRIS 3255 12 TRIS 0122 00101 TRIS 3255 TRIS 0122 00100 TRIS 3255 TRIS 0122 00099 TRIS 3255 TRIS 0122 00098 TRIS 3255 TRIS 0122 00097 TRIS 3255 TRIS 0122 00096 TRIS 3255 TRIS 0122 00095 TRIS 3255 TRIS 0122 00089 TRIS 3255 TRIS 0122 00079 TRIS 3255 TRIS 0122 00076 TRIS 3255 TRIS 0122 00075 TRIS 3255 TRIS 0122 00074 TRIS 3255 TRIS 0122 00050 TRIS 3255 TRIS 0122 00049 TRIS 3255 TRIS 0122 00047 TRIS 3255 TRIS 0122 00026 TRIS 3255 TRIS 0122 00025 TRIS 3255 TRIS 0122 00009 TRIS 3255 10 TRIS 0121 0223 TRIS 3255 TRIS 0121 0099 TRIS 3255 TRIS 0121 0087 TRIS 3255 TRIS 0121 00208 TRIS 3255 V2 TRIS 0121 00207 TRIS 3255 TRIS 0121 00206 TRIS 3255 TRIS 0121 00199 TRIS 3255 TRIS 0121 00198 TRIS 3255 TRIS 0121 00158 TRIS 3255 TRIS 0121 00121 TRIS 3255 TRIS 0121 00109 TRIS 3255 TRIS 0121 00100 TRIS 3255 TRIS 0121 00044 TRIS 3255 05 TRIS 0121 00039 TRIS 3255 TRIS 0121 00028 TRIS 3255 TRIS 0121 00027 TRIS 3255 TRIS 0121 00022 TRIS 3255 TRIS 0121 00021 TRIS 3255 TRIS 0121 00012 TRIS 3255 TRIS 0121 00011 TRIS 3255 TRIS 0121 00010 TRIS 3255 TRIS 0121 00004 TRIS 3255 TRIS 0121 00003 TRIS 3255 TR3255 023 0121 TR3255 022 1220 TR3255 021 1220 TR3255 020 1220 TR3255 018 1020 TR3255 017 0920 TR3255 016 0820 TR3255 015 0820 TR3255 014 0820 TR3255 013 0820 TR3255 012 0820 TR3255 011 0820 TR3255 010 0520 TR3255 009 0520 TR3255 008 0320 TR3255 001 1119

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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