Natriumdihydrogenorthofosfat monohydrat 98.0-103.0% USP, Multi-Compendial, J.T.Baker®
Leverantör: Avantor
Synonyms:
Sodium phosphate monobasic monohydrate, Sodium dihydrogen orthophosphate monohydrate, Monosodium phosphate monohydrate, Sodium dihydrogenorthophosphate monohydrate, Sodium orthophosphate monobasic monohydrate
Management of Change (MOC) category = HR
3802-01EA
1675
SEK
3802-01
3802-07
3802-05
3802-25
3802-60
Natriumdihydrogenorthofosfat monohydrat 98.0-103.0% USP, Multi-Compendial, J.T.Baker®
Natriumdihydrogenorthofosfat monohydrat
Maximise the stability of your pharmaceutical formulations and get predictable pH control with reliable, proven buffering agents from Avantor™ Performance Materials.
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Formel:
NaH₂PO₄·H₂O MW: 137,99 g/mol Smältpunkt: 100 °C Densitet: 2,04 g/cm³ Storage Temperature: Omgivande |
MDL Number:
MFCD00149208 CAS nummer: 10049-21-5 EINECS: 231-449-2 REACH: 01-2119489796-13 Merck Index: 13,08734 |
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Specifikation testresultat
| GMP Manufactured Product | 98.0 - 103.0% |
| Meets U.S.P Requirements | Passes Test |
| Meets B.P. Chemical Specifications | ≤8 ppm |
| CAUTION: For Manufacturing, processing or repackaging | ≤0.014% |
| Bulk Pharmaceutical Chemical | Passes Test |
| Appearance (White crystals or granules) | Passes Test |
| USP - Assay (anhydrous basis) | 98.0 - 103.0 % |
| USP - Aluminum, Calcium, and Related Elements | Passes Test |
| USP - Arsenic (As) | ≤ 8 ppm |
| USP - Chloride (Cl) | ≤ 0.014 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Insoluble Substances | ≤ 0.2 % |
| USP - pH (1 in 20) | 4.1 - 4.5 |
| USP - Sulfate (SO₄) | ≤ 0.15 % |
| USP - Water (H₂O) | 10.0 - 15.0 % |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Identification C | Passes Test |
| EP - Assay (anhydrous basis) | 98.0 - 100.5 % |
| EP - Chloride (Cl) | ≤ 200 ppm |
| EP - Sulfate (SO₄) | ≤ 300 ppm |
| EP - Reducing Substances | Passes Test |
| Endotoxin Concentration (EU/g) | ≤ 2.5 |
| EP - Iron (Fe) | ≤ 10 ppm |
| EP - Appearance of Solution | Passes Test |
| EP - pH | 4.2 - 4.5 |
| BP - Identification A | Passes Test |
| BP - Identification B | Passes Test |
| BP - Identification C | Passes Test |
| BP - Identification D | Passes Test |
| BP - Acidity | 4.2 - 4.5 |
| BP - Clarity and Color of Solution | Passes Test |
| BP - Arsenic (As) | ≤ 2 ppm |
| BP - Iron (Fe) | ≤ 10 ppm |
| BP - Chloride (Cl) | ≤ 200 ppm |
| BP - Sulfate (SO₄) | ≤ 300 ppm |
| BP - Reducing Substances | Passes Test |
| BP - Loss on Drying at 130°C | 11.5 - 14.5 % |
| BP - Assay (dried basis) | 98.0 - 100.5 % |
| JPE - Assay (dried basis) | ≥ 98.0 % |
| JPE - Identification | Passes Test |
| JPE - pH | 4.1 - 4.7 |
| JPE - Clarity and Color of Solution | Passes Test |
| JPE - Chloride (Cl) | ≤ 0.005 % |
| JPE - Sulfate (SO4) | ≤ 0.019 % |
| JPE - Heavy Metals | ≤ 10 ppm |
| JPE - Arsenic (As) | ≤ 2 ppm |
| For EP notated requirements, results are derived from testing Sodium | |
| Phosphate, Monobasic Monohydrate, U.S.P. to the EP Chemical | |
| specifications for Sodium Dihydrogen Phosphate Dihydrate. | |
| For JPE notated requirements, results are derived from testing Sodium | |
| Phosphate, Monobasic Monohydrate, U.S.P. to the JPE Chemical | |
| 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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