Tromethamine (Tris) Multicompendial, LBLE
BIO EXCIPIENT GRADE | TR3255 | CAS# 77-86-1
INTENDED FOR USE AS AN EXCIPIENT


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
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- NAFTA Statement
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Test Methods
- IRGAFOS
- Stability Report
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 |
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White, crystalline powder to needle-like crystals | |||
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99.0-101.0% | |||
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Passes Test | |||
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Passes Test | |||
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Passes Test | |||
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1.0% max. | |||
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168-172oC | |||
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10.0-11.5 | |||
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0.1% max. |
EP Compendia
ANALYSIS |
SPECIFICATIONS |
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Passes Test | ||
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99.0-100.5% | ||
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≤ 100ppm | ||
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Passes Test | ||
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168-172°C | ||
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Passes Test | ||
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Passes Test | ||
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10ppm max. | ||
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0.5% max. | ||
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10.0-11.5 | ||
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≤ 1.0% | ||
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0.1% max. |
JPC Analysis
ANALYSIS |
SPECIFICATIONS |
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1.6 ppm max. | |||
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99.0-101.0% | |||
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Passes Test | |||
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8 ppm max. | |||
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Passes Test | |||
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Passes Test | |||
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0.5% max. | |||
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168-172oC | |||
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10.3-10.7 | |||
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0.1% max. |
ANALYSIS |
SPECIFICATIONS |
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0.06 a.u. max. 0.06 a.u. max. 0.01 a.u. max. |
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0.03 a.u. max. 0.02 a.u. max. 0.004 a.u. max. |
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0.2 a.u. max. |
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20 APHA max. |
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99.9% min |
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≤ 2.5 EU/g |
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None Detected None Detected None Detected |
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1ppm max. |
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0.005% max. |
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2.0% max. |
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0.3% max. |
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≤ 100 CFU/g ≤ 100 CFU/g |
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0.1% max. |
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0.05% max. |
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< 1.6 ppm |
Key Compliance Attributes of BioSpectra Grades |
Bio Excipient Grade ICH Q7 Compliant Manufactured |
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes |
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