tri-Sodio citrato dihidrato 99.0-105.0% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
Proveedor: Avantor
3647-01EA
91.64
EUR
3647-01
3647-05
3647-07
3647-20
3647-35
3647-37
tri-Sodio citrato dihidrato 99.0-105.0% (by anhydrous basis), granular USP, Multi-Compendial, J.T.Baker®
tri-Sodio citrato dihidrato
- GMP manufactured product
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Formula:
Na₃C₆H₅O₇·2H₂O Pto. de fusión: 150 °C Densidad: 1,70 g/cm³ Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00150031 Núm. CAS: 6132-04-3 EINECS: 200-675-3 Índice Merck: 13,08675 |
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Resultados test especificaciones
| GMP Manufactured Product | Passes Test |
| Meets E.P. Chemical Specifications | Passes Test |
| Meets B.P. Chemical Specifications | Passes Test |
| Meets U.S.P Requirements | Passes Test |
| Meets J.P. Chemical Specifications | 10.0 - 13.0% |
| CAUTION: For Manufacturing, processing or repackaging | Passes Test |
| Bulk Pharmaceutical Chemical | 99.0 - 100.5% |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C | Passes Test |
| USP - Alkalinity | Passes Test |
| USP - Water (H₂O) | 10.0 - 13.0 % |
| USP - Tartrate | Passes Test |
| USP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 100.5 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Readily Carbonizable Substances | Passes Test |
| EP/BP - Chloride (Cl) | ≤50 ppm |
| EP/BP - Oxalate (C₂O₄) | ≤300 ppm |
| EP/BP - Sulfate (SO₄) | ≤150 ppm |
| EP/BP - Water (H₂O) | 11.0 - 13.0 % |
| EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
| EP/BP - Endotoxin Concentration (EU/g) | ≤2.5 |
| JP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
| JP - pH (1 in 20) | 7.5 - 8.5 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Chloride (Cl) | ≤0.015 % |
| JP - Identification | Passes Test |
| JP - Sulfate (SO₄) | ≤0.048 % |
| JP - Heavy Metals (as Pb) | ≤10 ppm |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Tartrate | Passes Test |
| JP - Oxalate (C₂O₄) | Passes Test |
| JP - Readily Carbonizable Substances | Passes Test |
| JP - Loss on Drying at 180°C | 10.0 - 13.0 % |
| Total Aerobic Microbial Count, For Information Only | |
| Total Yeasts and Molds Count, For Information Only | |
| E. coli | Negative |
| P. aureginosa | Negative |
| 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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