tri-Sodium citrate dihydrate ≥99.0%, crystals, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, E331, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
Sodium Citrate, Dihydrate
, Citric acid trisodium salt dihydrate
, Sodium Citrate Dihydrate
, Sodium citrate tribasic dihydrate
, Sodium 2-hydroxypropane-1,2,3-tricarboxylate dihydrate
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 (*).
Certifications: Corresponds to Ph. Eur., BP, JP, USP, E 331
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Formula:
Na₃C₆H₅O₇·2H₂O MW: 294.1 g/mol Melting Pt: 150 °C (anhydr.) |
MDL Number:
MFCD00150031 CAS Number: 6132-04-3 Merck Index: 13,08675 |
Specification Test Results
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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