Tris Excipient BET, CP

BIO EXCIPIENT GRADE | TR3251

INTENDED FOR USE AS AN EXCIPIENT

Product-image
formula-image

BIO EXCIPIENT GRADE|TR3251

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

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.

 

ANALYSIS

SPECIFICATIONS

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

TAMC

TYMC 

≤ 1000 CFU/g≤

≤ 100 CFU/g

Color and Clarity of Solution (NF)  

A720 – ≤ 0.050

A420 – A720 ≤ 0.100

Chloride  
0.01% max.
 Endotoxin Concentration  
≤ 30 EU/g
Enzymes

DNase

Protease

RNase 

None Detected

None Detected

None Detected

Heavy Metals (Pb)  
5 ppm max.
Identification B  
Passes Test
Identification C
 
Passes Test
Identification (IR) (JP) 
Passes Test
Insoluble Matter (JP) 
0.005% max.
Karl Fischer Water 2% max.
Loss on Drying  
0.6% max.
Melting Range  
168 – 172 ºC
Microorganisms

Bile tolerant Gram Neg. Bacteria

Escherichia coli

Pseudomonas aeruginosa

Staphylococcus aureus

Candida albicans

Salmonella sp

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 1g

Absence in 1g

pH (5%)

 

10.0 – 11.5
Related Substances (TLC)  

1% max.

Residue on Ignition  
0.1% max
Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Nickel (Ni) 

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

5 ppm max.

15 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
No files available right now.
 

General Product Description:

  • The manufacturing of Tromethamine TR3251 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 TR3251 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, TR3251 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products including use in further manufacturing of parenteral grade products. This grade of Tromethamine is not sterile and requires terminal sterilization. It is not intended for use as an API, final 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:

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.

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 Tables 1, 2, 3, or 4.