Tromethamine (Tris) - Active

BIO ACTIVE GRADE | TR2220 | CAS# 77-86-1

INTENDED FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

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Tromethamine is used to treat metabolic acidosis, an electrolyte imbalance.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

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BIO ACTIVE GRADE / TR2220

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  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Yes
Custom Regulatory Packet  
Yes
Accelerated Stability  
Yes
Type IV Drug Master File  
N/A
Video Conference access to BioSpectra Sites  
Yes
Complete access to Product Traceability  
Yes
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
Suitable for use as Active Ingredient  
Yes
Type II Drug Master File  
Available
Find your C of As

General Product Description:

  • The Manufacturing of Tromethamine Bio Active grade is performed at BioSpectra’s Bangor, PA facility and is conducted utilizing multiuse equipment. Equipment used in the manufacture of TR2220 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • 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 TR2220 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 TR2220 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 between 15°C and 30°C.
  • Store in a clean and dry area.
  • Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.