Tromethamine (Tris) - Excipient

BIO EXCIPIENT GRADE | TR3220 | CAS# 77-86-1

C of As and Tech Docs

INTENDED FOR USE AS AN EXCIPIENT

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formula-image

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

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
Absorbance (40%) 290 nm
0.2 a.u. max.
Appearance and Color  
White / Crystals
Assay  
99.0–101.0%
Enzymes

DNase

RNase

Protease
None Detected
None Detected
None Detected
Heavy Metals  
5 ppm max.
Identification B  
Passes Test
Identification C  
Passes Test
Identification (IR)  
Passes Test
Insoluble Matter  
0.005% max.
Karl Fischer Water  
2.0% max.
Loss on Drying  
1.0% max.
Melting Range  
168–172˚C

pH (5%)

  
10.0–11.5
Residue on Ignition  
0.1% max.
Trace Metals Arsenic (As)
Calcium (Ca)
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium(Mg)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
List of C of As files
TR3220-015-1219.pdf
TR3220-014-1219.pdf
TR3220-013-1219.pdf
TR3220-012-0219.pdf
TR3220-011-0219.pdf
TR3220-010-0219.pdf
TR3220-009-0718.pdf
TR3220-008-0718.pdf
TR3220-007-0518.pdf
TR3220-006-0118.pdf
TR3220-005-1217.pdf

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

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.