Tromethamine (Tris) - GMP Buffer

BIO PHARMA GRADE | TR4220 | CAS# 77-86-1

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESS

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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 electro-
chromatography, 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.

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BIO PHARMA GRADE / TR4220

CAS #: 77-86-1

Molecular Formula:

C4H11NO3

Solubility in Water (g/L): 550

F.W.: 121.14 g/mol

pH @ 20°C: 10.0 - 11.5

Useful pH: 7.0 - 9.0

pKa @ 20˚C: 8.3

ANALYSIS SPECIFICATIONS
Absorbance (40%) 290 nm
0.2 a.u. maximum
Appearance and Color White / Crystals
Assay 99.0-101.0%
  DNase
Enzymes 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% maximum
Karl Fischer Water 2% maximum
Loss on Drying 1% maximum
Melting Range

168-172 ºC

pH (5%)

10.0-11.5

Residue on Ignition 0.1% max.
  Arsenic (As)
  Calcium (Ca)
Trace Elements  Copper (Cu)
  Iron (Fe)
  Lead (Pb)
  Magnesium (Mg)
                      5 ppm maximum
                      5 ppm maximum
                      5 ppm maximum
                      5 ppm maximum
                      5 ppm maximum
                      5 ppm maximum
Key Compliance Attributes of
BioSpectra Grades
Bio Pharma
Grade IPEC
GMP
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  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
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General Product Description:

  • The manufacturing of Tromethamine TR4220 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 TR4220 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 Active Grade Tromethamine TR4220 is manufactured in
accordance with cGMP guidelines and is suitable to be used only
as the following: ICH Q7 Compliant cGMP Manufactured Active
Pharmaceutical Ingredient for use in drug product manufacturing.
This Grade of Tromethamine is not suitable to be used as a sterile
or injectable Active Pharmaceutical Ingredient, 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.