Sodium Fluoride BP
Sodium Fluoride BP
Sodium Fluoride BP
General Notices
(Ph. Eur. monograph 0514)
NaF 41.99 7681-49-4
Action and use
Used in prevention of dental caries.
Preparations
Sodium Fluoride Mouthwash
Sodium Fluoride Oral Drops
Sodium Fluoride Oral Solution
Sodium Fluoride Tablets
Ph Eur
DEFINITION
Content
98.5 per cent to 100.5 per cent (dried substance).
CHARACTERS
Appearance
White or almost white powder or colourless crystals.
Solubility
Soluble in water, practically insoluble in ethanol (96 per cent).
IDENTIFICATION
A. To 2 mL of solution S (see Tests) add 0.5 mL of calcium chloride solution R. A
gelatinous white precipitate is formed that dissolves on adding 5 mL of ferric
chloride solution R1.
B. To about 4 mg add a mixture of 0.1 mL of alizarin S solution R and 0.1 mL
of zirconyl nitrate solution Rand mix. The colour changes from red to yellow.
C. Solution S gives reaction (a) of sodium (2.3.1).
TESTS
Solution S
Dissolve 2.5 g in carbon dioxide-free water R without heating and dilute to 100 mL
with the same solvent.
Appearance of solution
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).
Acidity or alkalinity
Dissolve 2.5 g of potassium nitrate R in 40 mL of solution S and dilute to 50 mL
with carbon dioxide-free water R. Cool to 0 °C and add 0.2 mL of phenolphthalein
solution R. If the solution is colourless, not more than 1.0 mL of 0.1 M sodium
hydroxide is required to produce a red colour that persists for at least 15 s. If the
solution is red, not more than 0.25 mL of 0.1 M hydrochloric acid is required to
change the colour of the indicator.
Chlorides (2.4.4)
Maximum 200 ppm.
Dilute 10 mL of solution S to 15 mL with water R.
Fluorosilicates
Heat to boiling the neutralised solution obtained in the test for acidity or alkalinity
and titrate whilst hot. Not more than 0.75 mL of 0.1 M sodium hydroxide is
required to change the colour of the indicator to red.
Sulfates (2.4.13)
Maximum 200 ppm.
Dissolve 0.25 g in 10 mL of a 223 g/L solution of aluminium nitrate R. Add 5 mL
of distilled water R and 0.6 mL of hydrochloric acid R1. Prepare the standard by
mixing 0.6 mL of hydrochloric acid R1, 5 mL ofsulfate standard solution (10 ppm
SO4) R and 10 mL of a 223 g/L solution of aluminium nitrate R.
Loss on drying (2.2.32)
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 130 °C for
3 h.
ASSAY
Dissolve 0.100 g in water R and dilute to 60 mL with the same solvent. Titrate
with 0.1 M lanthanum nitrate, determining the end-point potentiometrically
(2.2.20) using a fluoride-selective indicator electrode and a silver-silver chloride
reference electrode.
1 mL of 0.1 M lanthanum nitrate is equivalent to 12.60 mg of NaF.
Ph Eur