Product Category

Reagent/Compendial

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS)
99.9% High Purity, Reagent GMP Grade

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

Product Code: TRIS-3257 | Previously: TR3257

Intended Use Statement


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

ANALYSIS

SPECIFICATIONS

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.
APHA Color, 20% Solution  
20 APHA max.
Assay (Ultrapure, Dried basis)
 
99.9% min
Chloride (Cl)  
≤ 20 ppm
Endotoxins  
≤ 2.5 EU/g
Enzymes

DNase

Protease

RNase

None

None

None

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

TAMC

TYMC

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

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.

 

List of C of As files
No files available right now.

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

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.

Retest Date:

The recommended retest period for Tromethamine is two 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

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