Exercise No.

Content Uniformity Test of Sodium Bicarbonate Tablets

OBJECTIVES:
1. To determine the content uniformity of sodium bicarbonate tablets as a quality control
measure to establish a uniform amount of active ingredients in every tablets.

MATERIALS:
- Sodium bicarbonate tablets, 325 mg
- Sulfuric acid, 0.1 N
- Methyl Red T.S
- Single pan analytical balance
- Mortar & pestle
- Erlenmeyer flask, 250 mL
- Pipet, 1 mL
- Aspirator pump
- Fisher stand
- Acid buret
- Forcep

ASSAY PROCEDURE:
1. Weigh 20 sodium bicarbonate tablets and determine the average weight using a single
pan analytical balance. Two tablets are supplied to each group. Weigh and assay each
tablet separately for content uniformity.
2. Powder each tablet finely in mortar and transfer accurately into an Erlenmeyer flask
3. Add 20 mL of distilled water to the mortar and add the washings to the Erlenmeyer
flask. Repeat the washing with another 10 mL of distilled water. Combine the washing
and mix well.
4. Add 3 drops of methyl red T.S
5. Titrate with 0.1 N sulfuric acid until a pink color is produced

Titer value: Each ml of 0.1 N H2SO4 is equivalent to 8.401 mg of NaHCO3

Calculate the content of NaHCO3 tablet using the formula:

V x N x mEq of NaHC O 3
NaHC O 3 content per tab= x average weight
weight of tab
Wherein the weight of tablet = 325 mg and the average weight is 324 mg

Using titer value:

V x N . F x titer
NaHC O 3 content per tab= x average weight
wt of tablet
Actual normality
N . F ( Normality factor )=
theoretical normality
0.04599 N
N . F=
0.1 N
¿ 0.4599
 content of NaHC O 3 tablet
% labeled amount = x 100
labeled claimed

USP Requirement: Sodium bicarbonate tablets contain not less than 95% and not more than
105% of the labeled amount of NaHC O 3. The content uniformity requirement is met if the
content of each of the 20 tablet is within the limits of not less than 85% and not more than
115.0 %.

QUESTIONS:
1. How do you determine the titer value?
2. Calculate the titer value of the following for 1 N H2S04:
a. KHCO3
b. K2CO3
c. CaCO3
3. Give the significance of Content Uniformity Test.
4. What is the chemical reaction involved in the assay?
5. If a 0.2561 g sample of sodium bicarbonate (94.2% NaHCO 3) is titrated with 0.9215 N
sulfuric acid, what volume of the acid is required to produce and end point?
 EXERCISE NO. 2:Content Uniformity Test of Sodium Bicarbonate Tablets

NAME:____________________________ YEAR AND SECTION: ____________________