LBLE Active Substance (API)
ICH-Q7 GMP Manufactured Active Drug SubstanceTROMETHAMINE (TRIS)
LBLE, USP, API Grade
Product Code: TRIS-2255 | Previously: TR2255
Intended Use Statement
Bio Active LBLE Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization.
Product Specifications
| ANALYSIS | SPECIFICATIONS | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
0.2 a.u. max | |||||||||
| Appearance and Color | White / Crystals | |||||||||
| Assay | 99.0-101.0% | |||||||||
| Bacterial Endotoxins | 1.0 EU/g max. | |||||||||
|
|
|||||||||
| Heavy Metals (as Pb) | ≤ 0.012 | |||||||||
|
Passes Test Passes Test Passes Test |
|||||||||
| Insoluble Matter | 0.005% max. | |||||||||
| Karl Fischer Water | 2.0% max. | |||||||||
| Loss on Drying | 1.0% max | |||||||||
| Melting Range |
168-172 ºC |
|||||||||
|
Negative Negative Negative Negative 100 CFU/g max. 10 CFU/g max. |
|||||||||
|
NMT 1 ppm
NMT 1 ppm NMT 1 ppm NMT 300 ppm NMT 1 ppm |
|||||||||
|
≤ 100 ppm ≤ 10 ppm |
|||||||||
| Residue on Ignition |
0.1% max. |
|||||||||
|
99.0–101.0% |
|||||||||
|
|
|||||||||
|
30% Control Threshold, ppm ≤ 0.005 ≤ 0.012 ≤ 0.036 ≤ 0.007 ≤ 0.012 ≤ 0.024 ≤ 0.080 ≤ 0.019 ≤ 0.238 ≤ 0.024 ≤ 0.024 ≤ 0.024 ≤ 0.024 ≤ 0.024 ≤ 0.190 ≤ 0.024 ≤ 0.024 ≤ 0.595 ≤ 0.214 ≤ 1.667 ≤ 3.571 ≤ 0.714 ≤ 1.429 ≤ 2.619 |
| Key Compliance Attributes of BioSpectra Grades | Bio Active 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 Active 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. |
| List of C of As files |
|---|
| No files available right now. |
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
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Test Methods
- IRGAFOS
- Accelerated Stability
- Degradation and Impurity
- Stability Report
- Nitrosamine Report
- Nitrosamine Method Validation Report
- Label Copy
TRIS-2255 | TR2255
CAS #: 77-86-1
Formula: C4H11NO3
Sol. In H20 @ 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 LBLE API Grade Tromethamine TRIS-2255 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of LBLE API Grade Tromethamine TRIS-2255 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
- 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-2255 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:
LBLE API Grade Tromethamine TRIS-2255 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for Tromethamine is two years from the date of manufacture.
Storage and Shipping Conditions:
- Store in a clean and dry area.
- Store in the original container.
Package Sizes:
10kg, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging