Product Category


ICH-Q7 GMP Manufactured Product

99.9% High Purity, USP, Reagent GMP Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured,
Reagent Grade Product

Product Code: TRIS-3257 | Previously: TR3257

Intended For Use As A High Purity Reagent Grade

For Critical Analytical, Diagnostic and Pharmaceutical Applications, and downstream manufacture of drug products where a high purity, high assay, GMP Tromethamine is required. Tris is a considered a “Good’s” buffer because it has low UV absorptivity, minimum reactivity, stable pH and is soluble in water.

Product Specifications



Absorbance (1M)




0.06 a.u. max.

0.06 a.u. max.

0.01 a.u. max.

Absorbance (10%)




0.03 a.u. max.

0.02 a.u. max.

0.004 a.u. max.

Absorbance (40%) 290nm
0.2 a.u. max.
APHA Color, 20% Solution  
20 APHA max.
Assay (Ultrapure, Dried basis)
99.9% min
Chloride (Cl)  
≤ 20 ppm
≤ 2.5 EU/g







Heavy Metals (as Pb)  
1 ppm max
Insoluble Matter  
0.005% max.
Karl Fischer Water  
1.0% max.
Loss on Drying  
0.3% max.
Melting Point  
168 - 172°C
Microbial Content



≤ 100 CFU/g

≤ 100 CFU/g

pH (5%)  
10.0 – 11.5
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


Residual Solvents: 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.

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.


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General Product Description:

  • The manufacturing of Tromethamine TRIS-3257 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-3257 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


Product Statements:

Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code TRIS-3257, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code TRIS-3257, is not derived from Plant or Animal Origin.

Metal Residue Statement: BioSpectra certifies that Tris, Product Code TRIS-3257, 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-3257, 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 Multicompendial TRIS-3257 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine Multicompendial is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


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

Additional Packaging Information