Tris(hydroxymethyl)aminomethan (TRIS, Trometamol) USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
|
Achtung
|
4101-09EA
0
CHF
4101-09
4101-07
Tris(hydroxymethyl)aminomethan (TRIS, Trometamol) USP, Multikompendial, J.T.Baker®
Tris(hydroxymethyl)aminomethane (TRIS, Trometamol)
|
Formel:
NH₂C(CH₂OH)₃ |
MDL Number:
MFCD00004679 CAS-Nummer: 77-86-1 |
Spezifikation Testergebnisse
| 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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