Product Category

LBLE Active Substance (API)

ICH-Q7 GMP Manufactured Active Drug Substance

TROMETHAMINE (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
Absorbance (40%) 290 nm
0.2 a.u. max
Appearance and Color White / Crystals
Assay 99.0-101.0%
Bacterial Endotoxins 1.0 EU/g max.
  DNase
Enzymes RNase
  Protease
None Detected
None Detected
None Detected
Heavy Metals (as Pb) ≤ 0.012
USP Identifications

A (IR)

B

C

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

Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella

Staphylococcus aureus

TAMC

TYMC

Negative

Negative

Negative

Negative

100 CFU/g max.

10 CFU/g max.

Organic Impurities

2-Nitropropane-1,3-diol

Tris(hydroxymethyl)nitromethane (EP Related Impurity)

2-Nitroethanol

Total Unspecified Impurities

Formaldehyde

NMT 1 ppm

 

NMT 1 ppm

NMT 1 ppm

NMT 300 ppm

NMT 1 ppm

pH

290 nm

≤ 100 ppm

≤ 10 ppm

Residue on Ignition

0.1% max.

Residual Solvents

Methanol

Nitromethane

99.0–101.0% 

Trace Elements Aluminum (Al)
Calcium (Ca)
Iron (Fe)
Magnesium (Mg)
0.40 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.
Elemental Impurities

 

Cadmium (Cd)

Lead (Pb)

Arsenic (As)

Mercury (Hg)

Cobalt (Co)

Vanadium (V)

Nickel (Ni)

Thallium (Tl)

Gold (Au)

Palladium (Pd)

Iridium (Ir)

Osmium (Os)

Rhodium (Rh)

Ruthenium (Ru)

Selenium

Silver (Ag)

Platinum (Pt)

Lithium (Li)

Antimony (Sb)

Barium (Ba)

Molybdenum (Mo)

Copper (Cu)

Tin (Sn)

Chromium (Cr)

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

Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Active Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image
Suitable for use as Active Ingredient  
Yes-image

Yes-imageindicates 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.

 

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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