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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

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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
COAs
click to view
TRIS 0124 00108 TRIS 3254 50 TRIS 0124 00156 TRIS 3254 TRIS 0124 00138 TRIS 3254 TRIS 0124 00083 TRIS 3254 TRIS 0124 00063 TRIS 3254 TRIS 0124 00043 TRIS 3254 TRIS 0124 00036 TRIS 3254 TRIS 0124 00024 TRIS 3254 TRIS 0124 00021 TRIS 3254 TRIS 0123 00170 TRIS 3254 TRIS 0123 00152 TRIS 3254 TRIS 0123 00020 TRIS 3254 25 TRIS 0122 00186 TRIS 3254 TRIS 0122 00176 TRIS 3254 TRIS 0122 00134 TRIS 3254 TRIS 0122 00133 TRIS 3254 TRIS 0122 00128 TRIS 3254 TRIS 0122 00125 TRIS 3254 TRIS 0122 00102 TRIS 3254 TRIS 0122 00082 TRIS 3254 TRIS 0122 00081 TRIS 3254 TRIS 0122 00080 TRIS 3254 TRIS 0121 00194 TRIS 3254 TRIS 0121 00147 TRIS 3254 TRIS 0121 00146 TRIS 3254 TRIS 0121 00145 TRIS 3254 TRIS 0121 00091 TRIS 3254 TRIS 01 21 00091 TRIS 3254 TR3254 012 0221 TR3254 011 0121 TR3254 010 1020 TR3254 009 0820 K001 TR3254 009 0820 G100 TR3254 008 0820 K001 TR3254 008 0820 G100 TR3254 007 0820 K001 TR3254 007 0820 G100 TR3254 006 0820 TR3254 005 0820 TR3254 004 0820 TR3254 003 0720 TR3254 002 0620

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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Bangor, PA 18013 USA
610.599.3400

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