Titration Application Note T-192

Determination of acid-neutralizing
capacity according to USP general
chapter <301>

Antacids neutralize excess stomach acidity to relieve heartburn, sour stomach,

acid indigestion, and stomach upset. They are also used to relieve the pain of
stomach and duodenal ulcers. The acid-neutralizing capacity (ANC) of an antacid
is the amount of acid that can be neutralized. Commercial antacids containing
one or more bases are available to treat this condition by neutralizing the excess
acid in the stomach. Antacids are available with various formulations as over the
counter drugs (OTC). USP<301> describes a back titration method to a set
endpoint of pH 3.5 to determine the acid-neutralizing capacity. This Application
Note shows the determination of the ANC of alumina magnesia, magaldrate as
well as simethicone oral suspension and simethicone chewable tablet.
 Method description

Sample Calibration
Magaldrate and simethicone oral suspension pH calibration is done using Metrohm buffer solutions
(pH buffer 4, 7 and 9)
Alumina, magnesia, and simethicone chewable tablets

Analysis
Sample preparation
30 mL of c(HCl) = 1 mol/L (1 N) is accurately dosed to the
Magaldrate and simethicone oral suspension prepared sample. The content is stirred well for 15 min.
Sample container is shaken well. 5.63 g (equivalent to The excess hydrochloric acid is titrated immediately with
5 mL, single dose) of sample is weighed accurately and c(NaOH) = 0.5 mol/L (0.5 N) until a stable pH of 3.5 is
transferred into 150 mL glass beaker. 70 mL of carbon achieved.
dioxide free water is added and the content is stirred well
for 1 minute.
Parameters
Alumina, magnesia and simethicone chewable tablets
20 tablets are weighed accurately and transferred into a Titration mode SET pH
clean mortar. The average weight is noted. Tablets are Stirring rate 9
grinded into fine powder. From this, 1 g (single dose) of
Pause 900 s
sample is weighed accurately and transferred into
150 mL glass beaker. 70 mL of carbon dioxide free water EP1 at pH 3.5
is added and the content is stirred well for 1 minute. Dynamics pH 1.5
Maximum rate 20 mL/min
Configuration Minimum rate 5 µL/min
905 Titrando 2.905.0010 Stop criterion Drift
801 Magnetic stirrer 2.801.0040 Stop drift 30 µL/min
800 Dosino, 2x 2.800.0010 Titration direction Auto
Unitrode with Pt1000 6.0258.600 Extraction time 0s
50 mL Dosing unit, 2x 6.3032.250 Stop volume 50 mL
Tiamo 2.5 full CD: 1licence 6.6056.252
Buffer solution pH 4 6.2307.100 Results

Buffer solution pH 7 6.2307.110 Magaldrate and simethicone oral suspension

Buffer solution pH 9 6.2307.120 Acid neutralization capacity s(rel) / %
/ (mEq), (n = 5)
Solutions 11.56 0.29
*USP criteria - Acid neutralization capacity NLT 9.02.
Titrant c(NaOH) = 0.5 mol/L (0.5 N)
Around 20 g sodium
hydroxide is weighed Alumina, magnesia and simethicone chewable tablets
accurately and transferred
into a clean 1000 mL Acid neutralization capacity s(rel) / %
volumetric flask. It is then / (mEq), (n = 5)
dissolved and diluted up to 7.67 0.87
the mark with carbon
dioxide free water. *USP criteria - Acid neutralization capacity NLT 7.00.
HCl solution c(HCl) = 1 mol/L (1 N)
87 ml hydrochloric acid
Version 1, published in June 2018

(37%) is taken in a clean 1 L

Titration Application Note T-192

volumetric flask. It is diluted

to the mark with carbon
dioxide free water.
 Method description

Comments
Besides the herein described alumina magnesia,
magaldrate as well as simethicone oral suspension and
simethicone chewable tablets, the following samples can
be analyzed:
 Alumina and magnesia oral suspension,
 Alumina and magnesia tablets,
 Alumina and magnesium carbonate OS,
 Alumina and magnesium carbonate tablets,
 Alumina and magnesium trisilicate OS,
 Alumina and magnesium trisilicate tablets,
 Alumina, magnesia and calcium carbonate
chewable tablets,
 Alumina, magnesia and calcium carbonate
oral suspension,
 Alumina, magnesia and simethicone chewable
tablets,
 Alumina, magnesia and simethicone oral
suspension,
 Alumina, magnesium carbonate and
magnesium oxide tablets,
 Aluminum hydroxide gel,
 Aspirin effervescent tablets for OS,
 Aspirin, alumina and magnesia tablets,
 Aspirin, alumina and magnesium oxide tablets,
 Aspirin, codeine phosphate, alumina and
magnesia tablet,
 Buffered aspirin tablets,
 Calcium and magnesium carbonates oral
Suspension,
 Calcium and magnesium carbonates tablets.
 Calcium carbonate and magnesia chewable
tablets,
 Calcium carbonate and magnesia tablets,
 Calcium carbonate lozenges,
 Calcium carbonate tablets,
 Calcium carbonate, magnesia, and
simethicone chewable tablets,
 Didanosine tablets for OS,
 Dihydroxyaluminum aminoacetate magma,
 Dihydroxyaluminum sodium carbonate
chewable tablets,
 Dihydroxyaluminum sodium carbonate,
 Dried aluminum hydroxide gel capsules,
 Dried aluminum hydroxide gel tablet,
 Dried aluminum hydroxide gel,
 Magaldrate oral suspension

Version 1, published in June 2018

Magaldrate tablets,
Titration Application Note T-192

 Magnesia tablets,
 Magnesium oxide capsules,
 Magnesium oxide tablets