Disodium hydrogen phosphate, anhydrous 98.0-100.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Warning
|
Management of Change (MOC) category = R
CH05-07EA
0
EUR
CH05-07
Disodium hydrogen phosphate, anhydrous 98.0-100.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
Disodium hydrogen phosphate
Formula:
Na₂HPO₄ MW: 141,96 g/mol |
MDL Number:
MFCD00003496 CAS Number: 7558-79-4 |
Specification Test Results
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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