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Excipient

ICH-Q7 GMP Manufactured Product

Tris Excipient

USP, EP, LBLE*, GMP, Excipient Grade

*Low Bioburden, Low Endotoxin

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

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Product Code: TRIS-3254 | Previously: TR3254
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 (USP)
Appearance and Color  
White/Crystals
Assay  
99.0 – 101.0%
Endotoxin  
≤ 2.5 EU/g
Identification A

 

Passes Test
Identification B  

Passes Test
Identification C  
Passes Test
Loss on Drying  
≤ 1.0%
Melting Range

 

168 - 172ºC
pH (1 in 20)  
10.0 – 11.5
Residue on Ignition  
≤ 0.1%
Microbial Content

TAMC

TYMC

≤ 500 CFU/g

≤ 200 CFU/g
 
 
 

ANALYSIS

SPECIFICATIONS (EP)
Appearance of Solution  
Passes Test
Assay  
99.0-100.5%
Chloride (Cl) ≤ 100 ppm
Identification A  
Passes Test
Identification B
 
168 - 174°C
Identification C  

Passes Test
Iron (Fe)

 
< 10ppm
Loss on Drying at 105ºC  

≤0.5%
pH  
10.0 – 11.5
Related Substances

 

≤ 1.0%
Sulfated Ash  

≤ 0.1%

 

Printable Version

General Product Description:

  • The manufacturing of Tromethamine TRIS-3254 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-3254 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

GMP Compliance:

Bio Excipient Grade Tromethamine TRIS-3254 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.

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.

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:

10kg, 25kg and 50kg pails. 

Tech Docs

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.

100 Majestic Way
Bangor, PA 18013 USA
610.599.3400

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