Tris(hydroxymethyl)aminomethane (TRIS, Trometamol) USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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Warning
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BAKR4101-09EA
0
SGD
BAKR4101-09
BAKR4101-07
Tris(hydroxymethyl)aminomethane (TRIS, Trometamol) USP, Multi-Compendial, J.T.Baker®
Tris(hydroxymethyl)aminomethane (TRIS, Trometamol)
Formula:
NH₂C(CH₂OH)₃ |
MDL Number:
MFCD00004679 CAS Number: 77-86-1 |
Specification Test Results
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets JPC (1997) Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₄H₁₁NO₃) | 99.0 - 101.0 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - pH (1 in 20) | 10.0 - 11.5 |
USP - Residue on Ignition | ≤0.1 % |
USP - Loss on Drying | ≤0.5 % |
USP - Melting Range(Lower) | 168 - 172 °C |
USP - Melting Range(Upper) | 168 - 172 °C |
EP/BP - Assay (C₄H₁₁NO₃) (dried basis) | 99.0 - 100.5 % |
EP/BP - Identification B | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH | 10.0 - 11.5 |
EP/BP - Related Substances | ≤1.0 % |
EP/BP - Chloride (Cl) | ≤100 ppm |
EP/BP - Iron (Fe) | ≤10 ppm |
EP/BP - Loss on Drying at 105°C | ≤0.5 % |
EP/BP - Ash (sulfated) | ≤0.1 % |
JPC 1997 - Assay (C₄H₁₁NO₃) (dried basis) | ≥99.0 % |
JPC 1997 - Identification A | Passes Test |
JPC 1997 - Identification B | Passes Test |
JPC 1997 - pH | 10.3 - 10.7 |
JPC 1997 - Melting Point | 168 - 172 °C |
JP - Clarity and Color of Solution | Passes Test |
JPC 1997 - Heavy Metals (as Pb) | ≤8 ppm |
JPC 1997 - Arsenic (As) | ≤1.6 ppm |
JPC 1997 - Loss on Drying | ≤0.5 % |
JPC 1997 - Residue on Ignition | ≤0.10 % |
Assay (C₄H₁₁NO₃) (dried basis) | ≥99.9 % |
Absorbance of a 1M Solution - 260 nm | ≤0.06 |
Absorbance of a 1M Solution - 280 nm | ≤0.06 |
Absorbance of a 1M Solution - 400 nm | ≤0.01 |
Endotoxin Concentration (EU/g) | ≤2.5 |
Iron (Fe) | ≤1 ppm |
Lead (Pb) | ≤1 ppm |
Water (H₂O)(by Karl Fischer titrn) | ≤0.5 % |
Enzyme Activity - DNase Activity | Passes Test |
Enzyme Activity - RNase Activity | Passes Test |
Enzyme Activity - Protease Activity | Passes Test |
Trace Impurities - Arsenic (As) | ≤1 ppm |
Trace Impurities - Aluminum (Al) | ≤5.000 ppm |
Trace Impurities - Barium (Ba) | ≤5 ppm |
Trace Impurities - Bismuth (Bi) | ≤5 ppm |
Trace Impurities - Calcium (Ca) | ≤10.0 ppm |
Trace Impurities - Cadmium (Cd) | ≤5.000 ppm |
Trace Impurities - Chromium (CR) | ≤5 ppm |
Trace Impurities - Cobalt (Co) | ≤5.000 ppm |
Trace Impurities - Copper (Cu) | ≤5 ppm |
Trace Impurities - Lithium (Li) | ≤5 ppm |
Trace Impurities - Magnesium (Mg) | ≤5 ppm |
Trace Impurities - Mercury (Hg) | ≤5 ppm |
Trace Impurities - Molybdenum (Mo) | ≤5 ppm |
Trace Impurities - Nickel (Ni) | ≤5.000 ppm |
Trace Impurities - Potassium (K) | ≤50 ppm |
Trace Impurities - Sodium (Na) | ≤50.000 ppm |
Trace Impurities - Strontium (Sr) | ≤5 ppm |
Trace Impurities - Vanadium (V) | ≤5.000 ppm |
Trace Impurities - Zinc (Zn) | ≤5.000 ppm |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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