Sodium fluorure, EMPROVE® API USP, Ph. Eur., BP suitable for use as an active pharmaceutical ingredient, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
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Danger
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1.06441.1000
1.06441.9025
1.06441.1000EA
711
EUR
1.06441.1000
1.06441.9025
Sodium fluorure, EMPROVE® API USP, Ph. Eur., BP suitable for use as an active pharmaceutical ingredient, SAFC®
Sodium fluorure
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: Conforms to Ph. Eur., BP, USP
Formule:
NaF MW: 41.99 g/mol Point d'ébullition: 1700 Point de fusion: 996 °C Densité: 2.8 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00003524 Numéro CAS: 7681-49-4 EINECS: 231-667-8 ONU: 1690 ADR: 6.1 III Merck Index: 13,08691 |
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Résultats des tests de spécification
Assay (Precipitative Titration, Calculated on Dried Substance) | 98.5 - 100.5% |
Identity | Passes Test |
Appearance of solution | Clear and Colourless |
Alkalinity (as NaOH) | ≤0.1% |
Acidity (as HF) | ≤0.2% |
Chloride (Cl) | ≤0.01% |
Hexafluorosilicate (SiF₆) | ≤0.1% |
Sulfate (SO₄) | ≤0.02% |
Heavy metals (as Pb) | ≤0.003% |
Fe (Iron) | ≤0.005% |
Loss on Drying (150 °C, 4 h) | ≤0.5% |
Residual solvents (Ph. Eur./USP/ICH) | Excluded by Manufacturing Process |
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