Tromethamine (Tris) Multicompendial, LBLE

BIO EXCIPIENT GRADE | TR3255 | CAS# 77-86-1

INTENDED FOR USE AS AN EXCIPIENT

Product-image
formula-image

BIO EXCIPIENT GRADE |TR3255

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

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.


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

USP Compendia

ANALYSIS

SPECIFICATIONS
Appearance and Color  
White, crystalline powder to needle-like crystals
Assay (dried basis)  
99.0-101.0%
Identification A  
Passes Test
Identification B  
Passes Test
Identification C
 
Passes Test
Loss on Drying  
1.0% max.
Melting Range  
168-172oC
pH (1 in 20)  
10.0-11.5
Residue on Ignition  
0.1% max.

EP Compendia

ANALYSIS

SPECIFICATIONS
Appearance of Solution  
Passes Test
Assay (dried basis)  
99.0-100.5%
Chloride (Cl)  
≤ 100ppm
Identification A  
Passes Test
Identification B (Melting Range)  
168-172°C
Identification C  
Passes Test
Identification D  
Passes Test
Iron (Fe)  
10ppm max.
Loss on Drying @ 105°C  
0.5% max.
pH (5%)  
10.0-11.5
Related Substances  
≤ 1.0%
Sulfated Ash  
0.1% max.

JPC Analysis

ANALYSIS

SPECIFICATIONS
Arsenic (As)  
1.6 ppm max.
Assay (dried basis)  
99.0-101.0%
Clarity and Color of Solution  
Passes Test
Heavy Metals
 
8 ppm max.
Identification A
 
Passes Test
Identification B  
Passes Test
Loss on Drying  
0.5% max.
Melting Point  
168-172oC
pH  
10.3-10.7
Residue on Ignition  
0.1% max.

 

ANALYSIS

SPECIFICATIONS
Absorbance (1M)

260nm

280nm

430nm

0.06 a.u. max.

0.06 a.u. max.

0.01 a.u. max.
Absorbance (10%)

260nm

280nm

430nm

0.03 a.u. max.

0.02 a.u. max.

0.004 a.u. max.
Absorbance (40%)

290nm

0.2 a.u. max.
APHA Color, 20% Solution  

20 APHA max.
Assay (dried basis)  

99.9% min
Endotoxins  

≤ 2.5 EU/g
Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected
Heavy Metals (as Pb)  

1ppm max.
Insoluble Matter  

0.005% max.
Karl Fischer Water  

2.0% max.
Loss on Drying  

0.3% max.
Microbial Content

TAMC

TYMC

≤ 100 CFU/g

≤ 100 CFU/g
Related Substances  

0.1% max.
Residue on Ignition  

0.05% max.
Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)
Zinc (Zn)

< 1.6 ppm
< 1 ppm
< 1 ppm
< 1 ppm
< 1 ppm
< 5 ppm
< 1 ppm
< 1 ppm

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
TR3255-023-0121.pdf
TR3255-022-1220.pdf
TR3255-021-1220.pdf
TR3255-020-1220.pdf
TR3255-018-1020.pdf
TR3255-017-0920.pdf
TR3255-016-0820.pdf
TR3255-015-0820.pdf
TR3255-014-0820.pdf
TR3255-013-0820.pdf
TR3255-012-0820.pdf
TR3255-011-0820.pdf
TR3255-010-0520.pdf
TR3255-009-0520.pdf
TR3255-008-0320.pdf
TR3255-001-1119.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 TR3255 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 TR3255 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

 

Product Statements:

  • Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code TR3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code TR3255, is not derived from Plant or Animal Origin.
  • Metal Residue Statement: BioSpectra certifies that Tris, Product Code TR3255, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.
  • Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code TR3255, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.
  • 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 <467> Tables 1, 2, 3, or 4.


GMP Compliance:

Bio Excipient Grade Tromethamine TR3255 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured non- Sterile Excipient for use in further Manufacturing. This Grade of Tromethamine is not suitable to be used as a Sterile or Injectable Excipient, Active Pharmaceutical Ingredient, Drug Product or Household Item.

Expiration/Reset 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:

10 kg and 25 kg pails and 50 kg drums