ICH Q7 GMP Manufactured Active Ingredient
USP, LBLE*, GMP, API
Product Code: TRIS-2255
*Low Bioburden, Low Endotoxin
Minimum Order Quantity: 250kg
Lead Time: 7-months
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.
CAS #: 77-86-1
Formula: NH2C(CH2OH)3
F.W.: 121.14 g/mol
Solubility at 25˚C: 550 mg/mL
pH (5% aq. Solution): 10.0 - 11.5
pKa at 25˚C: 8.07
| 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 | |||||||||
|
None Detected None Detected None Detected |
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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 |
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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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Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).
Refer to SDS.
10kg, 25kg, and 50kg
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.