University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL

PROFESSIONS DEPARTMENT OF PHARMACY
PharChem3: Quality Control 1: Drug Testing and Assay
(Laboratory)

NAME: REY BRONDA JR. DATE: 16/05/2021

YR AND SECTION: PH 1E

MODULE 3

Percent API Content per Tablet

3.1. PREPARATION AND STANDARDIZATION OF 0.1 N SULFURIC ACID

Discuss the preparation and standardization 0.1 N Sulfuric acid (Identify the primary standard, indicator,
titrant and indicator used)

Primary standard. Sodium carbonate

Indicator. Methyl red
Titrant. Sodium carbonate
Indicator used. Methyl red

According to pharmaceutical guidelines, the preparation and standardization of 0.1 N sulfuric acid are
the following;

Preparation of sulfuric acid.

- Add slowly, with stirring, 6 ml of sulfuric acid to about 800 ml of purified water.
- Make up to 1000 ml with purified water.
- Allow cooling at 25*C.

Sulfuric acid solution standardization.

- Weigh accurately about 0.2 g of anhydrous sodium carbonate, previously heated at about 270*C
for 1 hour.
- Dissolve it inn 100 ml of water and add 0.1 ml of methyl red solution.
- Add the acid slowly from a burette, with constant stirring, until the solution becomes faintly
pink.
- Heat the solution to boiling, cool and continue the titration.
- Heat again to boiling and titrate further as necessary until the faint pink color is no longer
affected by continued boiling.
- 1 ml of 0.1 M sulfuric acid is equivalent to 0.0098 g of Na2CO3.
- Calculate the molarity of the solution by the following formula;
- M= Na2CO3 in mg / H2SO4 in ml (9.8).
3.2. CONTENT UNIFORMITY TEST OF SODIUM BICARBONATE TABLETS
Discuss the preparation and standardization 0.1 N Sulfuric acid (Identify the primary standard, indicator,
titrant and indicator used)

Primary standard. Hydrochloric acid

Indicator. Methyl red
Titrant. Hydrochloric acid
Indicator used. Methyl red TS

According to U.S. pharmacopeia the test in sodium bicarbonate is the following;

Weigh and finely powder not less than 20 tablets.

Weigh accurately a portion of the powder, equivalent to about 2 g of sodium bicarbonate,
dissolve in water, add methyl red TS, and titrate with 1 N hydrochloric acid VS.
Add the acid slowly, with stirring, until the solution becomes faintly pink.
Heat the solution to boiling, cool, and continue the titration until the pink color no longer fades
after boiling.
Each ml of 1 N hydrochloric acid is equivalent to 84.01 mg of NaHCO3.

3.3. GUIDE QUESTIONS

1. What are the other ways of standardizing sulfuric acid?

According to labmonk.com, the other way of standardization of sulfuric acid is by the use of
sodium hydroxide.

Take 20 ml of sodium hydroxide solution into a clean conical flask with addition of 2-3 drops of methyl
orange as indicator. Perform titration with H2SO4 present in burette. Note the end point when yellow
color changes to orange color. Repeat the experiment with two successive readings are concurrent.

2. Chemical reaction involved in Exercise 3.1.

The chemical reaction involved in exercise 3.1 is Na2CO3 + H2SO4 to produce Na2SO4 + CO2 +
H2O.

3. If 25 mL sulphuric acid solution were required in the titration of 0.3592 g pure sodium carbonate,
what is the normality of the solution? (Show your solution)

since 1M=1N, we can use this formula.

N= Na2CO3 in mg / H2SO4 in ml (9.8).
359.2 𝑚𝑔
𝑁= 25 (9.8)
= 𝟏. 𝟒𝟕 𝑵
4. A 500 mg sodium bicarbonate tablet weighs 499.54 mg and was used in an assay. The titration of the
sample used up 30 mL of 0.1 N sulfuric acid. Compute for the NaHCO3 contained in the tablet and its %
label claim. Each mL of 0.1 N H2SO4 is equivalent to 8.401 mg of NaHCO3. (Show your solution)
𝑉.𝑁.𝑚𝐸𝑞
%= 𝑤
𝑥100
30 𝑚𝑙 (0.1 𝑁)(0.008401 𝑔)
%= 0.49954 𝑔
𝑥100
% =5.05%

5. A 500 mg sodium bicarbonate tablet weighs 499.54 mg and was used in an assay. The titration of the
sample used up 30 mL of 0.1214 N sulfuric acid. Compute for the NaHCO3 contained in the tablet and its
label claim. Each mL of 0.1N H2SO4 is equivalent to 8.401 mg of NaHCO3. (Show your solution)
0.1 𝑁 8.401 𝑚𝑔
0.1214
= 𝑥
0.1214 𝑁 = 10.20 𝑚𝑔
Each 0.1214 N H2SO4 is equivalent to 10.20 mg of NaHCO3

𝑉.𝑁.𝑚𝐸𝑞
%= 𝑥100
𝑤
30 𝑚𝑙 (0.1214 𝑁)(0.01020 𝑔)
%= 0.49954 𝑔
𝑥100
% =7.44%

References.

preparation and standardization 0.1 N Sulfuric acid retrieved from

https://www.pharmaguideline.com/2010/09/preparation-and-standardization-of-01-m-H2SO4.html

preparation and standardization 0.1 N Sulfuric acid retrieved from https://labmonk.com/preparation-

and-standardization-of-sulfuric-acid

Content uniformity test of sodium bicarbonate tablets retrieved from

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m75900.html