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Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS)
Ch.P., GMP Excipient Grade

Product Code: TRIS-3251 | Previously: TR3251

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Intended For Use As An Excipient


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.

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M) 

260nm 

280nm 

430nm 

≤ 0.06 a.u. 

≤ 0.06 a.u. 

≤ 0.01 a.u. 

Absorbance (10%) 

260nm 

280nm 

430nm

≤ 0.03 a.u. 

≤ 0.02 a.u. 

≤ 0.004 a.u. 

Absorbance (40%) 
290nm 

≤ 0.2 a.u. 

APHA Color, 20% Solution 

 

≤ 20 APHA 

Appearance and Color
 

White/Crystals 

Appearance of Solution (EP)
 
Passes Test

Assay (Dried Basis) (USP/EP/ChP/JPC) 

 

99.0% – 100.5% 

Assay (Ultrapure, Dried Basis) 
 

≥ 99.9% 
Chloride (ChP/EP)

 ≤ 100 ppm 

Clarity and Color of Solution (ChP/JPC) 
 
Passes Test
Endotoxins  

 ≤ 2.5 EU/g 
Enzymes DNase
Protease
RNase 

None Detected
None Detected
None Detected

Heavy Metals (as Pb) (ChP/JPC) 
 

 ≤ 1 ppm 

Identification IR, (USP-A/ChP-3/EP-C) 

 

Passes Test

Identification A (JPC) 
 
Passes Test
Identification B (USP/ChP-1)  

Passes Test
Identification B (JPC)  
Passes Test
Identification C (USP)

 

Passes Test

Identification D (EP/ChP-2)

Passes Test

Insoluble Matter

≤ 0.005%
Karl Fischer Water ≤ 1.0%
Loss on Drying (USP/ChP/EP/JPC) ≤ 0.3% 
Melting Range (USP/ChP/IDB-EP/JPC)  168 - 172°C
Methanol ≤ 3000 ppm
Microbial Content

TAMC
TYMC
Bile tolerant Gram Neg. Bacteria
Escherichia Coli
Pseudomonas aeruginosa
Staphylococcus aureus
Candida albicans
Salmonella sp 

≤ 100 CFU/g
≤ 100 CFU/g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 10g
pH (5%) (USP/IDA-EP/ChP) 10.0 – 11.5
pH (1 in 100) (JPC) 10.3 – 10.7
Related Substances (ChP/EP) ≤ 0.1%
Residue on Ignition/Sulfated Ash (USP/ChP/EP/JPC) ≤ 0.05%
Trace Metals

Arsenic (As)
Calcium (Ca)
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium (Mg)
Manganese (Mn)
Nickel (Ni)
Zinc (Zn)

≤ 1.6 ppm
≤ 1 ppm
≤ 1 ppm
≤ 1 ppm
≤ 1 ppm
≤ 5 ppm
≤ 1 ppm
≤ 15 ppm
≤ 1 ppm
 
Printable Version
List of C of As files
TRIS-0123-00169_TRIS-3251.pdf
TRIS-0123-00158_TRIS-3251.pdf
TRIS-0123-00132_TRIS-3251.pdf
TRIS-0124-00054_TRIS-3251.pdf
TRIS-0124-00049_TRIS-3251.pdf
TRIS-0124-00047_TRIS-3251.pdf
TRIS-0124-00047_TRIS-3251_5kg.pdf
TRIS-0123-00168_TRIS-3251.pdf
TRIS-0123-00132_TRIS-3251-05.pdf
TRIS-0123-00131_TRIS-3251-01.pdf
TR3251-012-0121_TRIS-3251-05.pdf
TR3251-012-0121_TRIS-3251-01.pdf
TR3251-012-0121_TRIS-3251-10.pdf
TRIS-0122-00077_TRIS-3251.pdf
TRIS-0121-00184_TRIS-3251.pdf
TR3251-012-0121 K010.pdf
TR3251-012-0121 K005.pdf
TR3251-011-0820.pdf
TR3251-010-0820.pdf
TR3251-009-0820.pdf
TR3251-008-0320.pdf
TR3251-007-0320.pdf

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COAs and Tech Docs

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formula-image

TRIS-3251 TR3251

CAS #: 77-86-1

Formula: C4H11NO3

Sol. In H2O @ 25°C (g/L): 550

F.W.: 121.14 g/mol

pH @ 20°C 5% aq.: 10.0 - 11.5

Useful pH: 7.0 - 9.0

pKa @ 20˚C: 8.3

General Product Description:

  • The manufacturing of Tromethamine TRIS-3251 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 TRIS-3251 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, Chinese Pharmacopeia TRIS-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine, Chinese Pharmacopeia 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:

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 <467> Tables 1, 2, 3, or 4.

Additional Packaging Information

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