di-Natriumhydrogen fosfat, vattenfri 98.0-100.5% USP, Multi-Compendial, J.T.Baker®
Leverantör: Avantor|
Varning
|
Synonyms:
sec-Sodium phosphate, di-Sodium hydrogen orthophosphate, di-Sodium hydrogen phosphate anhydrous, Sodium hydrogen phosphate, Disodium phosphate, Sodium phosphate dibasic
Management of Change (MOC) category = R
3804-01EA
1100
SEK
3804-01
3804-07
3804-65
di-Natriumhydrogen fosfat, vattenfri 98.0-100.5% USP, Multi-Compendial, J.T.Baker®
di-Natriumhydrogen fosfat
GMP Manufactured Product
Meets E.P. Chemical Specifications
Meets JPE Specifications
Meets U.S.P Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
- GMP manufactured product
|
Formel:
Na₂HPO₄ MW: 141,96 g/mol Smältpunkt: 250 °C Densitet: 2,07 g/cm³ (20 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00003496 CAS nummer: 7558-79-4 EINECS: 231-448-7 REACH: 01-2119489797-11 Merck Index: 12,08805 |
Specifikation testresultat
| Meets JPE Specifications | 98.0 - 100.5% |
| Meets E.P. Chemical Specifications | Passes Test |
| Meets U.S.P Requirements | ≤5.0% |
| GMP Manufactured Product | ≤0.4% |
| CAUTION: For Manufacturing, processing or repackaging | ≤0.06% |
| Bulk Pharmaceutical Chemical | ≤0.2% |
| 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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