Tromethamine (Tris) - Excipient
BIO EXCIPIENT GRADE | TR3220 | CAS# 77-86-1
INTENDED FOR USE AS AN EXCIPIENT


BIO EXCIPIENT GRADE / TR3220
CAS #: 77-86-1
Molecular Formula:
C4H11NO3
Solubility in Water @ 25°C (g/L): 550
F.W.: 121.14 g/mol
pH @ 20°C (5% aq. Soln.): 10.0 - 11.5
Useful pH: 7.0 - 9.0
pKa @ 20˚C: 8.3
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- NAFTA Statement
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Test Methods
- IRGAFOS
- Stability Report
Tris, commonly used as a buffer in biochemistry and molecular biology, stabilizes the pH of solutions in electrophoresis and other biological applications. It is also an enzyme inhibitor used in the biopharmaceutical industry and is commonly utilized in electrochromatography, UV analysis and HPLC applications. Tris is extensively used as a biological buffer or a component of buffer solutions. Tris can be used as a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
ANALYSIS | SPECIFICATIONS | |||
---|---|---|---|---|
|
|
|||
|
White / Crystals | |||
|
99.0–101.0% | |||
|
None Detected None Detected None Detected |
|||
|
5 ppm max. | |||
|
Passes Test | |||
|
Passes Test | |||
|
Passes Test | |||
|
0.005% max. | |||
|
2.0% max. | |||
|
1.0% max. | |||
|
168–172˚C | |||
|
10.0–11.5 | |||
|
0.1% max. | |||
|
5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
---|---|---|---|
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Yes | ||
|
Yes | ||
|
Yes |
General Product Description:
- The manufacturing of Tromethamine TR3220 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: NH2C(CH2OH)3
- 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 TR3220 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, Tri (Hydroxymethyl) Amino Methane.
GMP Compliance:
Bio Excipient Grade Tromethamine TR3220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient, for use in further Manufacturing. This Grade of Tromethamine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
Expiration/Retest Date:
The recommended retest period for Tromethamine is two years
from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.