tri-Sodium citrate dihydrate ≥99.0%, en cristales, EMPROVE® ESSENTIAL E331, BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
Sinónimos:
Citrato de trisodio dihidrato
1.06432.5000
1.06432.9029
1.06432.5000EA
654
EUR
1.06432.5000
1.06432.9029
tri-Sodium citrate dihydrate ≥99.0%, en cristales, EMPROVE® ESSENTIAL E331, BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®
tri-Sodio citrato dihidrato
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certificaciones: Corresponds to Ph. Eur., BP, JP, USP, E 331
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
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Formula:
Na₃C₆H₅O₇·2H₂O MW: 294.1 g/mol Pto. de fusión: 150 (anhidr.) 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
| Assay (Perchloric acid titration, calc. on anhydrous substance (Ph Eur)) | 99.0 - 101.0 % |
| Assay (Perchloric acid titration, previously dried substance) (JP/USP) | 99.0 - 100.5 % |
| Identity (Na) | passes test |
| Identity (Citrate) | passes test |
| Identity (reaction upon ignition) | passes test |
| Appearance | white to almost white crystals |
| Appearance of solution (100 g/l, CO₂-free water) | clear and colorless |
| Acidity or alkalinity | passes test |
| pH (50 g/l CO₂-free water) | 7.5 - 8.5 |
| Chloride (Cl) | ≤ 50 ppm |
| Sulfate (SO₄) | ≤ 150 ppm |
| Heavy metals (as Pb) | ≤ 5 ppm |
| Al (Aluminium) | ≤ 5 ppm |
| As (Arsenic) | ≤ 1 ppm |
| Hg (Mercury) | ≤ 1 ppm |
| Pb (Lead) | ≤ 1 ppm |
| Oxalate (as C₂H₂O₄) | ≤ 100 ppm |
| Tartrate (C₄H₄O₆) | passes test |
| Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
| Readily carbonisable substance | passes test |
| Water (according to Karl Fischer) | 11.0 - 13.0 % |
| Loss on drying (180 °C, 18 h) | 10.0 - 13.0 % |
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