di-Natriumhydrogen fosfat, vattenfri USP, Multi-Compendial HP, 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
4953-01EA
0
SEK
4953-01
di-Natriumhydrogen fosfat, vattenfri USP, Multi-Compendial HP, J.T.Baker®
di-Natriumhydrogen fosfat
|
Formel:
Na₂HPO₄ MW: 141,96 g/mol Smältpunkt: 250 °C Densitet: 1,53 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 | |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Meets E.P. Chemical Specifications | |
| 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 |
| JPE - Assay (dried basis) | ≥ 99.0 % |
| 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 |
| Endotoxin Concentration (EU/g) | ≤ 2.5 |
| Microbial Testing – Total Aerobic Microbial Count (USP) | ≤ 10 cfu/g |
| Microbial Testing – Total Yeast and Mold Count (USP) | ≤ 10 cfu/g |
| Microbial Testing - Salmonella (USP) | Negative |
| Microbial Testing - Escherichia coli (USP) | Negative |
| Microbial Testing - Staphylococcus aureus (USP) | Negative |
| Microbial Testing - Pseudomonas aeruginosa (USP) | Negative |
| Microbial Testing -Bile tolerant gram-negative bacteria | Negative |
| Microbial Testing – Clostridia | Negative |
| Microbial Testing - Candida albicans | Negative |
| Trace Impurities - Cadmium (Cd) | ≤ 200 ppb |
| Trace Impurities - Lead (Pb) | ≤ 500 ppb |
| Trace Impurities - Arsenic (As) | ≤ 1500 ppb |
| Trace Impurities - Mercury (Hg) | ≤ 300 ppb |
| Trace Impurities - Cobalt (Co) | ≤ 500 ppb |
| Trace Impurities - Vanadium (V) | ≤ 1000 ppb |
| Trace Impurities - Nickel (Ni) | ≤ 2000 ppb |
| Trace Impurities - Thallium (Tl) | ≤ 800 ppb |
| Trace Impurities - Gold (Au) | ≤ 10000 ppb |
| Trace Impurities - Palladium (Pd) | ≤ 1000 ppb |
| Trace Impurities - Iridium (Ir) | ≤ 1000 ppb |
| Trace Impurities - Osmium (Os) | ≤ 1000 ppb |
| Trace Impurities - Rhodium (Rh) | ≤ 1000 ppb |
| Trace Impurities - Ruthenium (Ru) | ≤ 1000 ppb |
| Trace Impurities - Selenium (Se) | ≤ 8000 ppb |
| Trace Impurities - Silver (Ag) | ≤ 1000 ppb |
| Trace Impurities - Platinum (Pt) | ≤ 1000 ppb |
| Trace Impurities - Lithium (Li) | ≤ 25000 ppb |
| Trace Impurities - Antimony (Sb) | ≤ 9000 ppb |
| Trace Impurities - Barium (Ba) | ≤ 70000 ppb |
| Trace Impurities - Molybdenum (Mo) | ≤ 150000 ppb |
| Trace Impurities - Copper (Cu) | ≤ 30000 ppb |
| Trace Impurities - Tin (Sn) | ≤ 60000 ppb |
| Trace Impurities - Chromium (Cr) | ≤ 110000 ppb |
| 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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