Paracetamol BP

Paracetamol
General Notices
(Ph. Eur. monograph 0049)
C8H9NO2 151.2 103-90-2
Action and use
Analgesic; antipyretic.
Preparations
Co-codamol Tablets
Co-codamol Capsules
Effervescent Co-codamol Tablets
Effervescent Paracetamol Tablets
Co-dydramol Tablets
Co-proxamol Tablets
Paracetamol Capsules
Paediatric Paracetamol Oral Solution
Paediatric Paracetamol Oral Suspension
Paracetamol Oral Suspension
Paracetamol Suppositories
Paracetamol Tablets
Paracetamol and Caffeine Tablets
Soluble Paracetamol and Caffeine Tablets
Dispersible Paracetamol Tablets
Soluble Paracetamol Tablets
Paracetamol, Codeine Phosphate and Caffeine Capsules
Paracetamol, Codeine Phosphate and Caffeine Tablets
Ph Eur
DEFINITION
N-(4-Hydroxyphenyl)acetamide.
Content
99.0 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance
White or almost white, crystalline powder.
Solubility
Sparingly soluble in water, freely soluble in ethanol (96 per cent), very slightly
soluble in methylene chloride.
IDENTIFICATION
First identification: B.
Second identification: A.
A. Melting point (2.2.14).
Determination A Determine the melting point of the substance to be examined.
Result A 168 °C to 172 °C.
Determination B Mix equal parts of the substance to be examined
and paracetamol CRS and determine the melting point of the mixture.
Result B The absolute difference between the melting point of the mixture and the
value obtained in determination A is not greater than 2 °C.
B. Infrared absorption spectrophotometry (2.2.24).
Comparison paracetamol CRS.
TESTS
Related substances
Liquid chromatography (2.2.29).
Solvent mixture methanol R, water R (15:85 V/V).
Test solution Dissolve 50.0 mg of the substance to be examined in the solvent
mixture and dilute to 5.0 mL with the solvent mixture.
Reference solution (a) Dilute 1.0 mL of the test solution to 100.0 mL with the
solvent mixture. Dilute 1.0 mL of this solution to 20.0 mL with the solvent mixture.
Reference solution (b) Prepare immediately before use. Dissolve 5.0 mg
of paracetamol impurity K CRS and 5 mg of paracetamol CRS in the solvent
mixture and dilute to 100.0 mL with the solvent mixture. Dilute 1.0 mL of the
solution to 100.0 mL with the solvent mixture.
Reference solution (c) Dissolve 5.0 mg of paracetamol impurity J CRS in the
solvent mixture and dilute to 250.0 mL with the solvent mixture. Dilute 1.0 mL of
the solution to 200.0 mL with the solvent mixture.
Precolumn:
— size: l = 0.005 m, Ø = 2.1 mm;
— stationary phase: end-capped solid core octadecylsilyl silica gel for
chromatography R (2.7 µm).
Column:
— size: l = 0.10 m, Ø = 2.1 mm;
— stationary phase: end-capped solid core octadecylsilyl silica gel for
chromatography R (2.7 µm);
— temperature: 30 °C.
Mobile phase:
— mobile phase A: dissolve 1.7 g of potassium dihydrogen phosphate R and 1.8 g
of dipotassium hydrogen phosphate R in water for chromatography R and dilute to
1000 mL with the same solvent;
— mobile phase B: methanol R;
Time Mobile phase A Mobile phase B

(min) (per cent V/V) (per cent V/V)
0-1 95 5
1 - 10 95 → 90 5 → 10
10 - 20 90 10
20 - 40 90 → 66 10 → 34
40 - 50 66 34
Flow rate 0.3 mL/min.
Detection Spectrophotometer at 254 nm.
Injection 5 µL.
Identification of impurities Use the chromatogram obtained with reference
solution (b) to identify the peak due to impurity K; use the chromatogram obtained
with reference solution (c) to identify the peak due to impurity J.
Relative retention With reference to paracetamol (retention time = about 4 min):
impurity K = about 0.4; impurity J = about 10.1.
System suitability Reference solution (b):
— resolution: minimum 5.0 between the peaks due to impurity K and paracetamol.
Calculation of percentage contents:
— for impurity J, use the concentration of impurity J in reference solution (c);
— for impurity K, use the concentration of impurity K in reference solution (b);
— for impurities other than J and K, use the concentration of paracetamol in
reference solution (a).
Limits:
— impurity K: maximum 50 ppm;
— impurity J: maximum 10 ppm;
— unspecified impurities: for each impurity, maximum 0.05 per cent;
— total: maximum 0.2 per cent;
— reporting threshold: 0.03 per cent, except for impurities J and K.
Loss on drying (2.2.32)
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 °C.
Sulfated ash (2.4.14)
Maximum 0.1 per cent, determined on 1.0 g.
ASSAY
Dissolve 0.300 g in a mixture of 10 mL of water R and 30 mL of dilute sulfuric
acid R. Boil under a reflux condenser for 1 h, cool and dilute to 100.0 mL
with water R. To 20.0 mL of the solution add 40 mL of water R, 40 g of ice, 15 mL
of dilute hydrochloric acid R and 0.1 mL of ferroin R. Titrate with 0.1 M cerium
sulfate until a greenish-yellow colour is obtained. Carry out a blank titration.
1 mL of 0.1 M cerium sulfate is equivalent to 7.56 mg of C8H9NO2.

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Paracetamol

Time Mobile phase A Mobile phase B

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