Excipient
ICH-Q7 GMP Manufactured ProductTROMETHAMINE (TRIS)
USP, EP, LBLE (Standard)
GMP Excipient Grade
Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured
Product Code: TRIS-3254 | Previously: TR3254
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 (USP) |
||
|---|---|---|---|
|
White/Crystals | ||
|
99.0 – 101.0% | ||
|
≤ 2.5 EU/g | ||
|
Passes Test |
||
|
Passes Test |
||
|
Passes Test | ||
|
≤ 1.0% | ||
|
168 - 172ºC |
||
|
10.0 – 11.5 | ||
|
≤ 0.1% | ||
|
≤ 500 CFU/g ≤ 200 CFU/g |
|
ANALYSIS |
SPECIFICATIONS (EP) |
|||
|---|---|---|---|---|
|
Passes Test | |||
|
99.0-100.5% | |||
| Chloride (Cl) | ≤ 100 ppm | |||
|
Passes Test | |||
|
168 - 174°C | |||
|
Passes Test |
|||
|
< 10ppm | |||
|
≤0.5% |
|||
|
10.0 – 11.5 | |||
|
≤ 1.0% |
|||
|
≤ 0.1% |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
|---|---|---|---|
|
 |
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Test Methods
- IRGAFOS
- Stability Report
- Antiblock Additive Statement
- Nitrosamine Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- USMCA Statement
- Latex Statement
TRIS-3254 | TR3254
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-3254 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-3254 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 TRIS-3254 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
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.
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.
Additional Packaging Information
https://www.biospectra.us/technical/packaging