di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
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Achtung
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Synonyms:
Natriumorthophosphat dibasisch
, di-Natriumorthophosphat
, sek. Natriumphosphat
Veränderungsmanagement-Kategorie= R
CH05-07EA
0
CHF
CH05-07
di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
di-Natriumhydrogenphosphat
|
Formel:
Na₂HPO₄ MW: 141,96 g/mol |
MDL Number:
MFCD00003496 CAS-Nummer: 7558-79-4 |
Spezifikation Testergebnisse
| Meets U.S.P Requirements | |
| Meets ChP Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Identification | Passes Test |
| USP - Loss on Drying at 130°C | ≤ 5.0 % |
| USP - Insoluble Substances | ≤ 0.4 % |
| USP - Chloride (Cl) | ≤ 0.06 % |
| USP - Sulfate (SO₄) | ≤ 0.2 % |
| USP - Arsenic (As) | ≤ 16 ppm |
| USP - Endotoxin Concentration (2.5 EU/g max.) | Passes Test |
| JPE - Assay (dried basis) | ≥ 99.0 % |
| JPE - Arsenic (As) | ≤ 2 ppm |
| JPE - Identification | Passes Test |
| JPE - Carbonate | Passes Test |
| JPE - Chloride (Cl) | ≤ 0.011 % |
| JPE - Clarity and Color of Solution | Passes Test |
| JPE - Heavy Metals | ≤ 10 ppm |
| JPE - pH (1-100) | 9.0 - 9.4 |
| JPE - Sulfate (SO₄) | ≤ 0.038 % |
| JPE - Loss on Drying | ≤ 2.0 % |
| EP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| EP - Appearance of Solution | Passes Test |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Chloride (Cl) | ≤ 200 ppm |
| EP - Iron (Fe) | ≤ 20 ppm |
| EP - Loss on Drying | ≤ 1.0 % |
| EP - Monosodium Phosphate | ≤ 2.5 % |
| EP - Sulfate (SO₄) | ≤ 500 ppm |
| ChP - Identification | Passes Test |
| ChP - Alkalinity (pH) | 9.0 - 9.4 |
| ChP - Clarity and Color of Solution | Passes Test |
| ChP - Chloride | ≤ 0.001 % |
| ChP - Sulfate | ≤ 0.01 % |
| ChP - Carbonate | Passes Test |
| ChP - Water-insoluble substances | ≤ 0.05 % |
| ChP - Reducing substances | Passes Test |
| ChP - Loss on drying @ 130 C | ≤ 1.0 % |
| ChP - Heavy metals | ≤ 0.001 % |
| ChP - Arsenic | ≤ 0.0002 % |
| ChP - Assay (dried basis) | ≥ 99.0 % |
| ChP - Sodium dihydrogen phosphate | ≤ 2.5 % |
| ChP - Iron (Fe) | ≤ 0.002 % |
| 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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