di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
Achtung
|
Synonyme:
sek. Natriumphosphat
Veränderungsmanagement-Kategorie= R
3804-07EA
1002.46
EUR
3804-07
3804-08
3804-71
3804-65
3804-01
3804-77
di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
di-Natriumhydrogenphosphat
- GMP manufactured product
Formel:
Na₂HPO₄ Molecular Weight: 141,96 g/mol Schmelzpunkt: 250 °C Dichte: 2,07 g/cm³ (20 °C) Lagertemperatur: Raumtemperatur |
MDL:
MFCD00003496 CAS-Nummer: 7558-79-4 EINECS: 231-448-7 REACH: 01-2119489797-11 Merck Index: 12,08805 |
Spezifikation Testergebnisse
Meets JPE Specifications | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 - Identification | Passes Test |
JPE - Arsenic (As) | ≤ 2 ppm |
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 |
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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