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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

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.