Product Category

Buffer / Excipient

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS BASE)
USP, EP, JP, LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured, TRIS BASE

Product Code: TRIS-3255 | Previously: TR3255

Intended For Use As An Excipient


Tromethamine (TRIS BASE), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. TRIS BASE is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.

Product Specifications

ANALYSIS

SPECIFICATIONS (USP)

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.

 

ANALYSIS

SPECIFICATIONS (EP)

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.

 

ANALYSIS

SPECIFICATIONS (JPC)

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 (Other)

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  

1.0% 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

List of C of As files
TRIS-0124-00032_TRIS-3255.pdf
TRIS-0123-00297_TRIS-3255.pdf
TRIS-0124-00030_TRIS-3255.pdf
TRIS-0124-00022_TRIS-3255.pdf
TRIS-0124-00027_TRIS-3255.pdf
TRIS-0124-00025_TRIS-3255.pdf
TRIS-0123-00295_TRIS-3255.pdf
TRIS-0121-00044_TRIS-3255-05.pdf
TRIS-0123-00270_TRIS-3255.pdf
TRIS-0123-00267_TRIS-3255.pdf
TRIS-0123-00271_TRIS-3255.pdf
TRIS-0123-00259_TRIS-3255.pdf
TRIS-0121-00208_TRIS-3255-v2.pdf
TRIS-0123-00240_TRIS-3255.pdf
TRIS-0123-00239_TRIS-3255.pdf
TRIS-0123-00214_TRIS-3255.pdf
TRIS-0123-00200_TRIS-3255.pdf
TRIS-0123-00199_TRIS-3255.pdf
TRIS-0123-00198 -TRIS-3255.pdf
TRIS-0123-00174_TRIS-3255.pdf
TRIS-0123-00177_TRIS-3255.pdf
TRIS-0123-00176_TRIS-3255.pdf
TRIS-0123-00129_TRIS-3255-92.pdf
TRIS-0123-00128_TRIS-3255-92.pdf
TRIS-0123-00127_TRIS-3255-92.pdf
TRIS-0123-00156_TRIS-3255.pdf
TRIS-0123-00154_TRIS-3255.pdf
TRIS-0123-00153_TRIS-3255.pdf
TRIS-0123-00155_TRIS-3255.pdf
TRIS-0123-00115_TRIS-3255.pdf
TRIS-0123-00114_TRIS-3255.pdf
TRIS-0123-00108_TRIS-3255.pdf
TRIS-0123-00107_TRIS-3255.pdf
TRIS-0123-00106_TRIS-3255.pdf
TRIS-0123-00048_TRIS-3255.pdf
TRIS-0123-00025_TRIS-3255.pdf
TRIS-0123-00024_TRIS-3255.pdf
TRIS-0123-00012_TRIS-3255.pdf
TRIS-0123-00011_TRIS-3255.pdf
TRIS-0123-00010_TRIS-3255.pdf
TRIS-0123-00009_TRIS-3255.pdf
TRIS-0123-00008_TRIS-3255.pdf
TRIS-0122-00193_TRIS-3255.pdf
TRIS-0122-00187_TRIS-3255.pdf
TRIS-0122-00179_TRIS-3255.pdf
TRIS-0122-00177_TRIS-3255.pdf
TRIS-0122-00174_TRIS-3255.pdf
TRIS-0122-00173_TRIS-3255.pdf
TRIS-0122-00163_TRIS-3255.pdf
TRIS-0122-00161_TRIS-3255.pdf
TRIS-0222-00159_TRIS-3255.pdf
TRIS-0122-00154_TRIS-3255.pdf
TRIS-0122-00149_TRIS-3255.pdf
TRIS-0122-00142_TRIS-3255.pdf
TRIS-0122-00139_TRIS-3255.pdf
TRIS-0122-00127_TRIS-3255.pdf
TRIS-0122-00124_TRIS-3255.pdf
TRIS-0122-00123_TRIS-3255-12.pdf
TRIS-0122-00101_TRIS-3255.pdf
TRIS-0122-00100_TRIS-3255.pdf
TRIS-0122-00099_TRIS-3255.pdf
TRIS-0122-00098_TRIS-3255.pdf
TRIS-0122-00097_TRIS-3255.pdf
TRIS-0122-00096_TRIS-3255.pdf
TRIS-0122-00095_TRIS-3255.pdf
TRIS-0122-00089_TRIS-3255.pdf
TRIS-0122-00079_TRIS-3255.pdf
TRIS-0122-00076_TRIS-3255.pdf
TRIS-0122-00075_TRIS-3255.pdf
TRIS-0122-00074_TRIS-3255.pdf
TRIS-0122-00050_TRIS-3255.pdf
TRIS-0122-00049_TRIS-3255.pdf
TRIS-0222-00048_TRIS-3255.pdf
TRIS-0122-00047_TRIS-3255.pdf
TRIS-0122-00026_TRIS-3255.pdf
TRIS-0122-00025_TRIS-3255.pdf
TRIS-0122-00009_TRIS-3255-10.pdf
TRIS-0121-00207_TRIS-3255.pdf
TRIS-0121-00206_TRIS-3255.pdf
TRIS-0121-00199_TRIS-3255.pdf
TRIS-0121-00198_TRIS-3255.pdf
TRIS-0121-00158_TRIS-3255.pdf
TRIS-0121-00109_TRIS-3255.pdf
TRIS-0121-00121_TRIS-3255.pdf
TRIS-0121-00100_TRIS-3255.pdf
TRIS-0121-00004_TRIS-3255.pdf
TRIS-0121-00039_TRIS-3255.pdf
TRIS-0121-00022_TRIS-3255.pdf
TRIS-0121-00028_TRIS-3255.pdf
TRIS-0121-00027_TRIS-3255.pdf
TRIS-0121-00021_TRIS-3255.pdf
TRIS-0121-00012_TRIS-3255.pdf
TRIS-0121-00011_TRIS-3255.pdf
TRIS-0121-00010_TRIS-3255.pdf
TRIS-0121-00003_TRIS-3255.pdf
TRIS-0121-0099_TRIS-3255.pdf
TRIS-0121-0223_TRIS-3255.pdf
TRIS-0121-0087_TRIS-3255.pdf
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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General Product Description:

  • The manufacturing of Tromethamine TRIS BASE TRIS-3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • TRIS BASE 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 TRIS BASE TRIS-3255 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. TRIS BASE manufactured at BioSpectra and any raw materials used in the manufacture of TRIS BASE at BioSpectra are not subject to genetic modification.
  • Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane, TRIS BASE

 

Product Statements:

Plant or Animal Origin Statement: BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, is not derived from Plant or Animal Origin.

Metal Residue Statement: BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, 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
TRIS-3255, 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 (TRIS BASE) Multicompendial TRIS-3255 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine (TRIS BASE) Multicompendial is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Expiration:

The recommended expiration period for Tromethamine is three 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

Additional Packaging Information

https://www.biospectra.us/technical/packaging