Natriumdihydrogenphosphat Monohydrat 98,0-103,0% USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
Synonyms:
Natriumphosphat monobasisch Monohydrat
Veränderungsmanagement-Kategorie= HR
CH04-07EA
0
CHF
CH04-07
Natriumdihydrogenphosphat Monohydrat 98,0-103,0% USP, Multikompendial, J.T.Baker®
Natriumdihydrogenphosphat Monohydrat
|
Formel:
NaH₂PO₄·H₂O MW: 137,99 g/mol Melting Pt: 100 °C Dichte: 2,04 g/cm³ Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00149208 CAS-Nummer: 10049-21-5 EINECS: 231-449-2 REACH: 01-2119489796-13 Merck Index: 13,08734 |
Spezifikation Testergebnisse
| GMP Manufactured Product | |
| Meets ChP Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| 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 |
| ChP - Assay (dried basis) | ≥ 98.0 % |
| ChP - Identification | Passes Test |
| ChP - Acidity (pH) | 4.1 - 4.7 |
| ChP - Clarity and color of solution | Passes Test |
| ChP - Chlorides | ≤ 0.01 % |
| ChP - Sulfates | ≤ 0.05 % |
| ChP - Loss on Drying | 10.0 - 15.0 % |
| ChP - Aluminum | ≤ 0.01 % |
| ChP - Calcium | ≤ 0.01 % |
| ChP - Heavy metals | ≤ 0.001 % |
| ChP - Arsenic | ≤ 0.0002 % |
| ChP - Water insoluble substanc | ≤ 0.2 % |
| ChP - Reducing substances | Passes Test |
| ChP - Iron | ≤ 0.001 % |
| 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 | |
| specifications for Sodium Dihydrogen Phosphate Dihydrate. | |
| 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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