Citric Acid - British Pharmacopoeia

8/23/2020 Citric Acid - British Pharmacopoeia
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Citric Acid1
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General Notices
Anhydrous Citric Acid
(Ph. Eur. monograph 0455)
C6H8O7 192.1 77-92-9
Ph Eur
DEFINITION
2-Hydroxypropane-1,2,3-tricarboxylic acid.
Content
99.5 per cent to 100.5 per cent (anhydrous substance).
♦ CHARACTERS
Appearance
White or almost white, crystalline powder, colourless crystals or granules.
Solubility
Very soluble in water, freely soluble in ethanol (96 per cent).
mp
About 153 °C, with decomposition.♦
IDENTIFICATION
First identification: B,♢ E.
Second identification: A, C, D, E.
A. Dissolve 1 g in 10 mL of water R. The solution is strongly acidic (2.2.4).♢

B. Infrared absorption spectrophotometry (2.2.24).
Preparation Dry the substance to be examined and the reference substance at 105 ± 2 °C for 2 h.
Comparison anhydrous citric acid CRS.
♢ C. Add about 5 mg to a mixture of 1 mL of acetic anhydride R and 3 mL of pyridine R. A red colour develops.
D. Dissolve 0.5 g in 5 mL of water R, neutralise using 1 M sodium hydroxide (about 7 mL), add 10 mL of calcium chloride solution R and heat to boiling. A
white precipitate is formed.
E. Water (see Tests).♢
TESTS
Appearance of solution
https://www.pharmacopoeia.com/bp-2020/monographs/citric-acid1.html?date=2020-07-01&text=Citric+acid+anhydrous+ 1/3
The solution is clear (2.2.1) and colourless or not more intensely coloured than reference solution Y7, BY7 or GY7 (2.2.2, Method II).
Dissolve 2.0 g in water R and dilute to 10 mL with the same solvent.
Readily carbonisable substances
To 1.0 g in a cleaned test tube add 10 mL of sulfuric acid R and immediately heat the mixture in a water-bath at 90 ± 1 °C for 60 min. Cool rapidly
immediately afterwards. The solution is not more intensely coloured than a mixture of 1 mL of red primary solution and 9 mL of yellow primary solution
(2.2.2, Method I).
Oxalic acid
Maximum 360 ppm, calculated as anhydrous oxalic acid.
Dissolve 0.80 g in 4 mL of water R. Add 3 mL of hydrochloric acid R and 1 g of zinc R in granules. Boil for 1 min. Allow to stand for 2 min. Transfer the
supernatant to a test-tube containing 0.25 mL of a 10 g/L solution of phenylhydrazine hydrochloride R and heat to boiling. Cool rapidly, transfer to a
graduated cylinder and add an equal volume of hydrochloric acid R and 0.25 mL of a 50 g/L solution of potassium ferricyanide R. Shake and allow to stand
for 30 min. Any pink colour in the solution is not more intense than that in a standard prepared at the same time in the same manner using 4 mL of a
0.1 g/L solution of oxalic acid R.
Sulfates (2.4.13)
Maximum 150 ppm.
Dissolve 2.0 g in distilled water R and dilute to 30 mL with the same solvent.
Aluminium (2.4.17)
Maximum 0.2 ppm, if intended for use in the manufacture of dialysis solutions.
Prescribed solution Dissolve 20 g in 100 mL of water R and add 10 mL of acetate buffer solution pH 6.0 R.
Reference solution Mix 2 mL of aluminium standard solution (2 ppm Al) R, 10 mL of acetate buffer solution pH 6.0 R and 98 mL of water R.
Blank solution Mix 10 mL of acetate buffer solution pH 6.0 R and 100 mL of water R.
Water (2.5.12)
Maximum 1.0 per cent, determined on 2.000 g.
Sulfated ash (2.4.14)
Maximum 0.1 per cent, determined on 1.0 g.
♦ Bacterial endotoxins (2.6.14)
Less than 0.5 IU/mg, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial
endotoxins.♦
ASSAY
Dissolve 0.550 g in 50 mL of water R. Titrate with 1 M sodium hydroxide, using 0.5 mL of phenolphthalein solution R as indicator.
1 mL of 1 M sodium hydroxide is equivalent to 64.03 mg of C6H8O7.
♦ LABELLING
The label states, where applicable, that the substance is intended for use in the manufacture of dialysis solutions.♦
Ph Eur
1 This monograph has undergone pharmacopoeial harmonisation. See chapter 5.8 Pharmacopoeial harmonisation.
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8/23/2020 Citric Acid - British Pharmacopoeia

Anhydrous Citric Acid

(Ph. Eur. monograph 0455)

C6H8O7 192.1 77-92-9

99.5 per cent to 100.5 per cent (anhydrous substance).

White or almost white, crystalline powder, colourless crystals or granules.

Very soluble in water, freely soluble in ethanol (96 per cent).

About 153 °C, with decomposition.♦

First identification: B,♢ E.

A. Dissolve 1 g in 10 mL of water R. The solution is strongly acidic (2.2.4).♢

Comparison anhydrous citric acid CRS.

Dissolve 2.0 g in water R and dilute to 10 mL with the same solvent.

Readily carbonisable substances

Maximum 360 ppm, calculated as anhydrous oxalic acid.

Maximum 150 ppm.

Maximum 1.0 per cent, determined on 2.000 g.

Sulfated ash (2.4.14)

Maximum 0.1 per cent, determined on 1.0 g.

♦ Bacterial endotoxins (2.6.14)

1 mL of 1 M sodium hydroxide is equivalent to 64.03 mg of C6H8O7.

© Crown Copyright 2019

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