Lactic acid

EUROPEAN PHARMACOPOEIA 5.0

Inject separately 20 l of each solution. Continue the

chromatography for three times the retention time of the
principal peak. In the chromatogram obtained with the test
solution : the area of any peak, apart from the principal
peak, is not greater than 0.6 times that of the principal peak
in the chromatogram obtained with the reference solution
(0.3 per cent) ; the sum of the areas of any such peaks
is not greater than the area of the principal peak in the
chromatogram obtained with the reference solution (0.5 per
cent). Disregard any peak due to the solvent and any peak
with an area less than 0.1 times the area of the principal peak
in the chromatogram obtained with the reference solution.
Heavy metals (2.4.8). 1.0 g complies with limit test C for
heavy metals (20 ppm). Prepare the standard using 2 ml of
lead standard solution (10 ppm Pb) R.
Loss on drying (2.2.32). Not more than 1.0 per cent,
determined on 1.000 g by drying in an oven at 100 C to
105 C at a pressure not exceeding 0.7 kPa.
Sulphated ash (2.4.14). Not more than 0.1 per cent,
determined on 1.0 g.

CHARACTERS
Appearance : colourless or slightly yellow, syrupy liquid.
Solubility : miscible with water and with alcohol.
IDENTIFICATION
A. Dissolve 1 g in 10 ml of water R. The solution is strongly
acidic (2.2.4).
B. Relative density (2.2.5) : 1.20 to 1.21.
C. It gives the reaction of lactates (2.3.1).

TESTS
Solution S. Dissolve 5.0 g in 42 ml of 1 M sodium hydroxide
and dilute to 50 ml with distilled water R.
Appearance. The substance to be examined is not more
intensely coloured than reference solution Y6 (2.2.2,
Method II).
Ether-insoluble substances. Dissolve 1.0 g in 25 ml of
ether R. The solution is not more opalescent than the solvent
used for the test.
Sugars and other reducing substances. To 1 ml of solution S
ASSAY
add 1 ml of 1 M hydrochloric acid, heat to boiling, allow to
In order to avoid overheating in the reaction medium, mix cool and add 1.5 ml of 1 M sodium hydroxide and 2 ml of
thoroughly throughout and stop the titration immediately cupri-tartaric solution R. Heat to boiling. No red or greenish
after the end-point has been reached.
precipitate is formed.
Dissolve 0.200 g in a mixture of 10 ml of anhydrous
Methanol (2.4.24) : maximum 50 ppm, if intended for use in
formic acid R and 40 ml of acetic anhydride R. Titrate
the manufacture of parenteral dosage forms.
with 0.1 M perchloric acid, determining the end-point
Citric, oxalic and phosphoric acids. To 5 ml of solution S
potentiometrically (2.2.20).
add dilute ammonia R1 until slightly alkaline (2.2.4). Add
1 ml of 0.1 M perchloric acid is equivalent to 36.49 mg of
1 ml of calcium chloride solution R. Heat on a water-bath
C19H25ClN2O3.
for 5 min. Both before and after heating, any opalescence in
the solution is not more intense than that in a mixture of
IMPURITIES
1 ml of water R and 5 ml of solution S.
Sulphates (2.4.13) : maximum 200 ppm.
7.5 ml of solution S diluted to 15 ml with distilled water R
complies with the limit test for sulphates.
Calcium (2.4.3) : maximum 200 ppm.
5 ml of solution S diluted to 15 ml with distilled water R
complies with the limit test for calcium.
Heavy metals (2.4.8) : maximum 10 ppm.
A. R = H : 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-312 ml of solution S complies with limit test A. Prepare the
phenylpropyl)-amino]ethyl]benzoic acid,
standard using lead standard solution (1 ppm Pb) R.
B. R = CH3 : methyl 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3Sulphated ash (2.4.14) : maximum 0.1 per cent, determined
phenylpropyl)amino]ethyl]benzoate.
on 1.0 g.
Bacterial endotoxins (2.6.14) : less than 5 IU/g, if intended
01/2005:0458 for use in the manufacture of parenteral dosage forms
without a further appropriate procedure for the elimination
of bacterial endotoxins.

LACTIC ACID

Acidum lacticum

C 3 H 6 O3

ASSAY
Place 1.000 g in a ground-glass-stoppered flask and add
10 ml of water R and 20.0 ml of 1 M sodium hydroxide.
Close the flask and allow to stand for 30 min. Using 0.5 ml
of phenolphthalein solution R as indicator, titrate with 1 M
hydrochloric acid until the pink colour is discharged.
Mr 90.1 1 ml of 1 M sodium hydroxide is equivalent to 90.1 mg of
C3 H 6 O 3 .

DEFINITION
Mixture of 2-hydroxypropanoic acid, its condensation
products, such as lactoyl-lactic acid and polylactic acids, and
water. The equilibrium between lactic acid and polylactic
acids depends on the concentration and temperature. It is
usually the racemate ((RS)-lactic acid).
Content : 88.0 per cent m/m to 92.0 per cent m/m of C3H6O3.
1882

LABELLING
The label states :
where applicable, that the substance is free from bacterial
endotoxins,
where applicable, that the substance is suitable for use in
the manufacture of parenteral dosage forms.

See the information section on general monographs (cover pages)