ICH-Q7 GMP Manufactured Active Drug Substance
*Low Bioburden, Low Endotoxin
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.
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
| ANALYSIS | SPECIFICATIONS | |||||||||
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≤ 0.2 a.u. | |||||||||
| Appearance and Color | White / Crystals | |||||||||
| Assay | 99.0-101.0% | |||||||||
| Bacterial Endotoxins | ≤ 3.0 EU/g | |||||||||
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| Heavy Metals (as Pb) | ≤ 0.012 ppm | |||||||||
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Passes Test Passes Test Passes Test |
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| Insoluble Matter | ≤ 0.005% | |||||||||
| Karl Fischer Water | ≤ 2.0% | |||||||||
| Loss on Drying | ≤ 1.0% | |||||||||
| Melting Range |
168-172 ºC |
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Negative Negative Negative Negative ≤ 100 CFU/g ≤ 10 CFU/g |
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NMT 1 ppm NMT 1 ppm NMT 1 ppm NMT 15 ppm NMT 300 ppm NMT 300 ppm |
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10.0 – 11.5 |
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| Residue on Ignition |
≤ 0.1% |
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≤ 300 ppm ≤ 15 ppm |
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≤ 0.005 ppm ≤ 0.012 ppm ≤ 0.036 ppm ≤ 0.007 ppm ≤ 0.012 ppm ≤ 0.024 ppm ≤ 0.079 ppm ≤ 0.019 ppm ≤ 0.238 ppm ≤ 0.024 ppm ≤ 0.024 ppm ≤ 0.024 ppm ≤ 0.024 ppm ≤ 0.024 ppm ≤ 0.191 ppm ≤ 0.024 ppm ≤ 0.024 ppm ≤ 0.595 ppm ≤ 0.214 ppm ≤ 1.667 ppm ≤ 3.572 ppm ≤ 0.714 ppm ≤ 1.429 ppm ≤ 2.619 ppm |
Printable Version
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.
The recommended retest period for Tromethamine is two years from the date of manufacture.
10kg, 25kg and 50kg pails.
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.