Disodium phosphate
01/2021:1509 STORAGE
corrected 10.6 In an airtight container.
DISODIUM PHOSPHATE
Dinatrii phosphas
Na2HPO4 Mr 142.0
[7558-79-4]
DEFINITION
Content : 98.0 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance : white or almost white powder, hygroscopic.
Solubility : soluble in water, practically insoluble in ethanol
(96 per cent).
IDENTIFICATION
A. Solution S (see Tests) is slightly alkaline (2.2.4).
B. Loss on drying (see Tests).
C. Solution S gives reaction (b) of phosphates (2.3.1).
D. Solution S gives reaction (a) of sodium (2.3.1).
TESTS
Solution S. Dissolve 5.0 g in distilled water R and dilute to
100.0 mL with the same solvent.
Appearance of solution. Solution S is clear (2.2.1) and
colourless (2.2.2, Method II).
Reducing substances. To 10 mL of solution S add 5 mL of
dilute sulfuric acid R and 0.25 mL of a 3.2 g/L solution of
potassium permanganate R and heat on a water-bath for 5 min.
The colour of the permanganate is not completely discharged.
Monosodium phosphate : maximum 2.5 per cent.
From the volumes of 1 M sodium hydroxide (n1 mL, n2 mL and
n3 mL) used in the assay, calculate the following ratio :
n2 - n3
n3 - n1
This ratio is not greater than 0.025.
Chlorides (2.4.4): maximum 200 ppm.
Dilute 5 mL of solution S to 15 mL with dilute nitric acid R.
Sulfates (2.4.13) : maximum 500 ppm.
To 6 mL of solution S add 2 mL of dilute hydrochloric acid R
and dilute to 15 mL with distilled water R.
Iron (2.4.9): maximum 20 ppm, determined on solution S.
Loss on drying (2.2.32) : maximum 1.0 per cent, determined
on 1.000 g by drying in an oven at 105 °C for 4 h.
ASSAY
Dissolve 1.600 g (m) in 25.0 mL of carbon dioxide-free water R
and add 25.0 mL of 1 M hydrochloric acid. Carry out a
potentiometric titration (2.2.20) using 1 M sodium hydroxide. Iron (2.4.9) : maximum 40 ppm.
Read the volume added at the 1st inflexion point (n1 mL).
Continue the titration to the 2nd inflexion point (total volume
of 1 M sodium hydroxide required, n2 mL). Carry out a blank
titration (n3 mL).
Calculate the percentage content of Na2HPO4 from the
following expression :
1420 ( n3 - n1 )
m ( 100 - d)
d = percentage loss on drying.
2574
EUROPEAN PHARMACOPOEIA 11.
01/2021:0602
corrected 10.6
DISODIUM PHOSPHATE DIHYDRATE
Dinatrii phosphas dihydricus
Na2HPO4,2H2O Mr 178.0
[10028-24-7]
DEFINITION
Content : 98.0 per cent to 101.0 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. Solution S (see Tests) is slightly alkaline (2.2.4).
B. Loss on drying (see Tests).
C. Solution S gives reaction (b) of phosphates (2.3.1).
D. Solution S gives reaction (a) of sodium (2.3.1).
TESTS
Solution S. Dissolve 5.0 g in distilled water R 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).
Reducing substances. To 5 mL of solution S add 5 mL of
dilute sulfuric acid R and 0.25 mL of a 3.2 g/L solution of
potassium permanganate R and heat on a water-bath for 5 min.
The colour of the permanganate is not completely discharged.
Monosodium phosphate : maximum 2.5 per cent.
From the volumes of 1 M sodium hydroxide (n1 mL, n2 mL and
n3 mL) used in the assay, calculate the following ratio :
n2 - n3
n3 - n1
This ratio is not greater than 0.025.
Chlorides (2.4.4) : maximum 400 ppm.
To 2.5 mL of solution S add 10 mL of dilute nitric acid R and
dilute to 15 mL with water R.
Sulfates (2.4.13) : maximum 0.1 per cent.
To 3 mL of solution S add 2 mL of dilute hydrochloric acid R
and dilute to 15 mL with distilled water R.
Dilute 5 mL of solution S to 10 mL with water R.
Loss on drying (2.2.32) : 19.5 per cent to 21.0 per cent,
determined on 1.000 g by drying in an oven at 130 °C.
ASSAY
Dissolve 2.000 g (m) in 50 mL of water R and add 25.0 mL of
1 M hydrochloric acid. Carry out a potentiometric titration
(2.2.20) using 1 M sodium hydroxide. Read the volume added
at the 1st inflexion point (n1 mL). Continue the titration to
the 2nd inflexion point (total volume of 1 M sodium hydroxide
required, n2 mL). Carry out a blank titration (n3 mL).
See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 11.0 Disopyramide

Calculate the percentage content of Na2HPO4 from the at the 1st inflexion point (n1 mL). Continue the titration to
following expression : the 2nd inflexion point (total volume of 1 M sodium hydroxide
required, n2 mL). Carry out a blank titration (n3 mL).
1420 ( n3 - n1 )
Calculate the percentage content of Na2HPO4,12H2O using the
m ( 100 - d) following expression :
d = percentage loss on drying. 3581 ( n3 - n1 )
m ´ 100
01/2021:0118
corrected 10.6 04/2021:1006

DISODIUM PHOSPHATE DISOPYRAMIDE

DODECAHYDRATE
Dinatrii phosphas dodecahydricus
Na2HPO4,12H2O Mr 358.1
[10039-32-4]
DEFINITION
Content : 98.5 per cent to 102.5 per cent.
CHARACTERS
Appearance : colourless, transparent crystals, very efflorescent. C H N O
Solubility : freely soluble in water, practically insoluble in
ethanol (96 per cent).
IDENTIFICATION
A. Solution S (see Tests) is slightly alkaline (2.2.4).
B. Loss on drying (see Tests).
C. Solution S gives reaction (b) of phosphates (2.3.1).
D. Solution S gives reaction (a) of sodium (2.3.1).
TESTS
Solution S. Dissolve 5.0 g in distilled water R and dilute to
50 mL with the same solvent.
Appearance of solution. Solution S is clear (2.2.1) and
colourless (2.2.2, Method II).
Reducing substances. To 5 mL of solution S add 5 mL of
dilute sulfuric acid R and 0.25 mL of a 3.2 g/L solution of
potassium permanganate R and heat on a water-bath for 5 min.
The colour of the permanganate is not completely discharged.
Monosodium phosphate : maximum 2.5 per cent.
From the volumes of 1 M sodium hydroxide (n1 mL, n2 mL and
n3 mL) used in the assay, calculate the following ratio :
n2 - n3
n3 - n1
This ratio is not greater than 0.025.
Chlorides (2.4.4): maximum 200 ppm.
To 2.5 mL of solution S add 10 mL of dilute nitric acid R and
dilute to 15 mL with water R.
Sulfates (2.4.13) : maximum 500 ppm.
To 3 mL of solution S add 2 mL of dilute hydrochloric acid R
and dilute to 15 mL with distilled water R.
Iron (2.4.9) : maximum 20 ppm.
Dilute 5 mL of solution S to 10 mL with water R.
Loss on drying (2.2.32) : 57.0 per cent to 61.0 per cent,
determined on 1.000 g by drying in an oven at 130 °C for 4 h.
ASSAY
Dissolve 4.000 g (m) in 25 mL of water R and add 25.0 mL of solvent.
1 M hydrochloric acid. Carry out a potentiometric titration
(2.2.20) using 1 M sodium hydroxide. Read the volume added with methanol R.
Disopyramidum
Mr 339.5
21 29 3
[3737-09-5]
DEFINITION
(2RS)-4-[Di(propan-2-yl)amino]-2-phenyl-2-(pyridin-2-
yl)butanamide.
Content : 98.5 per cent to 101.5 per cent (anhydrous substance).
CHARACTERS
Appearance : white or almost white powder.
Solubility : slightly soluble in water, freely soluble in methylene
chloride, soluble in ethanol (96 per cent).
IDENTIFICATION
First identification : A.
Second identification : B.
A. Infrared absorption spectrophotometry (2.2.24).
Preparation : place 50 μL of a 50 g/L solution in methylene
chloride R on a disc of potassium bromide R. Dry the disc
at 60 °C for 1 h.
Comparison : disopyramide CRS.
B. Examine the chromatograms obtained in the test for related
substances.
Detection A : examine in ultraviolet light at 254 nm.
Results A : the principal spot in the chromatogram obtained
with test solution (b) is similar in position and size to
the principal spot in the chromatogram obtained with
reference solution (a).
Detection B : spray with dilute potassium iodobismuthate
solution R ; examine in daylight.
Results B : the principal spot in the chromatogram obtained
with test solution (b) is similar in position, colour and size
to the principal spot in the chromatogram obtained with
reference solution (a).
TESTS
Related substances. Thin-layer chromatography (2.2.27).
Test solution (a). Dissolve 0.20 g of the substance to be
examined in methanol R and dilute to 10 mL with the same
Test solution (b). Dilute 1 mL of test solution (a) to 10 mL

General Notices (1) apply to all monographs and other texts 2575