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1.06441 SAFC

Sodium fluoride

EMPROVE® API Ph Eur,BP,USP

Synonym: Sodium fluoride

  • CAS Number 7681-49-4

  • Empirical Formula (Hill Notation) FNa

  • Molecular Weight 41.99

  •  MDL number MFCD00003524

  •  EC Index Number 231-667-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Portfolio APIs More...
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   600
vapor pressure   1 hPa ( 1077 °C)
product line   Emprove® API
form   liquid
potency   148.5 mg/kg LD50, oral (Rat)
pH   10.2 (20 °C, 40 g/L in H2O)
mp   996 °C
density   2.8 g/cm3 at 20 °C
InChI   1S/FH.Na/h1H;/q;+1/p-1
InChI key   PUZPDOWCWNUUKD-UHFFFAOYSA-M
storage conditions   Store at +2°C to +25°C.

Description

Analysis Note

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
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 (*).
conforms to Ph Eur, BP, USP

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