di-Natriumhydrogenphosphat Heptahydrat 98,0-100,5% (Trockenmasse) USP, J.T.Baker®
Lieferant: Avantor
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Achtung
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Synonyms:
sek. Natriumphosphat Heptahydrat
, Natriumphosphat dibasisch Heptahydrat
Veränderungsmanagement-Kategorie= HR
J.T. Baker®
3803-07EA
1530
CHF
3803-07
3803-QM
3803-65
3803-01
3803-R
di-Natriumhydrogenphosphat Heptahydrat 98,0-100,5% (Trockenmasse) USP, J.T.Baker®
di-Natriumhydrogenphosphat Heptahydrat
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Formel:
HNa₂O₄P·7H₂O MW: 268,07 g/mol Melting Pt: 48 °C Dichte: 1,7 g/cm³ (20 °C) Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00149180 CAS-Nummer: 7782-85-6 EINECS: 231-448-7 |
Spezifikation Testergebnisse
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Appearance (Colorless or translucent crystals or granules) | Passes Test |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Arsenic (As) | ≤ 16 ppm |
| USP - Chloride (Cl) | ≤ 0.06 % |
| USP - Endotoxin Concentration (EU/g) | ≤ 2.5 |
| USP - Identification | Passes Test |
| USP - Insoluble Substances | ≤ 0.4 % |
| USP - Loss on Drying | 43.0 - 50.0 % |
| USP - Sulfate (SO₄) | ≤ 0.2 % |
| EP - Identification A | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Monosodium Phosphate | ≤ 2.5 % |
| EP - Chloride (Cl) | ≤ 200 ppm |
| EP - Sulfate (SO₄) | ≤ 500 ppm |
| EP - Appearance of Solution | Passes Test |
| EP - Iron (Fe) | ≤ 20 ppm |
| EP - Assay (dried basis) | 98.0 - 101.0 % |
| JP - Arsenic (As) | ≤ 2 ppm |
| JP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| JP - Carbonate (CO₃) | Passes Test |
| JP - Chloride (Cl) | ≤ 0.014 % |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Heavy Metals | ≤ 10 ppm |
| JP - Identification | Passes Test |
| JP - pH (1 in 50) | 9.0 - 9.4 |
| JP - Sulfate (SO₄) | ≤ 0.038 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| The EP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the EP chemical specifications derived from | |
| Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate. | |
| The JP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic | |
| Sodium Phosphate Hydrate. | |
| 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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