PHARMACEUTICAL ANALYSIS 1- QUANTITATIVE ANALYTICAL CHEMISTRY

LABORATORY MANUAL

ACTIVITY NO. 2
Weight Variation Test of Tablets Using Statistical Quality Control
INTRODUCTION
Weight variation test is a sort of test in which the average weight of a sample is contrasted to the sample's
individual weight of tablets. And using analytical balance to weigh the samples.

SCHEMATOC DIAGRAM

OBJECTIVES
1. To determine the % weight variation of tablets.
2. To apply statistical quality control.
3. To demonstrate understanding of the operation, use and care of Single Pan Analytical balance (Sauter balance).

MATERIALS
● Tablets
● Forceps
● Pencil
● Ruler
● Single Pan Analytical balance (Sauter balance)
● Soft tissue paper

PROCEDURE
A. WEIGHT VARIATION TEST
1. Weigh 20 tablets individually using a single pan analytical balance and record each. In this activity, each
weight will be given.
2. Find the average weight.
Formula:
Average weight= Total weight of 20 tablets
20 tablets

3. Determine the % weight variation of each of the tablets.

Formula:
% weight variation= Difference between actual wt. per tab & average weight of tab x 100
Average weight of tablets

4. The USP requirements for weight variation are met if the weight of not more than 2 of the tablets differs
from the average weight by more than the percentage listed in the USP and no tablet differs by more
than double that percentage.

USP Requirements for Weight Variation Tolerance for Compressed Tablets

Average weight of tablet (mg) % weight variation
130 or less 10%
130 to 324 7.5%
More than 324 5.0%

B. STATISTICAL QUALITY CONTROL

1. Fill the data needed in the table, wherein:
X = weight of each tablet
x̄ = average weight
2. Calculate the standard deviation using the formula:
 3. Calculate the mean, d, RAD, SD, RSD and R. Determine the Upper Control Limit (UCL) and Lower Control
Limit (LCL) using the formula:
UCL = x̄ + 3S
LCL = x̄ - 3S

4. Prepare the control chart by showing the weight of each tablet for y-axis and the number of each tablet for
x-axis using cross section graphing paper/bond paper.
5. Plot the graph and identify the average weight, UCL and LCL.
6. Interpret the result shown in the graph to determine if the batch of sample tablets is in compliance with the
USP or not.

C. RELATED QUESTIONS TO ANSWER

1. What is the weight variation test? Why are coated tablets exempt from weight variation test?
Weight variation test is a sort of test in which the average weight of a sample is contrasted to the sample's individual
weight of tablets.
Weight variation test is for examining the weight of the inner core of the tablets that is why coating tablets are
exempted. Also in the pharmaceutical industry, the weight of the outer crust and inner core of the tablets are measured
separately because coated tablets or the outer crust of a tablet dont have uniformity and it will give misinterpretation if
it is not measured separately

2. What are the other tests done for tablets that are official in the USP?
● Identification Tests
● Friability
● Disintegration
● Weight Variation
● Uniformity of Dosage Unit
● Dissolution
● assay
● Impurities

3. Enumerate the reasons why some tablets do not conform to the USP requirements?

4. Why should an analytical balance (such as Sauter balance) be used in weight variation test and not platform
or top loading balance?
The analytical balance is an extremely sensitive balance in laboratory equipment and can read around 0.0001

5. Illustrate and give the parts of a single pan analytical balance (Sauter balance)?
STATISTICAL QUALITY CONTROL DATA SHEET

A. WEIGHT VARIATION TEST

Tablet No. Net Weight per Tablet % Weight Variation

1 0.3633 1.91%

2 0.3609 1.23%

3 0.3622 1.60%

4 0.3589 0.67%

5 0.3590 0.70%

6 0.3584 0.53%

7 0.3573 0.22%

8 0.3593 0.79%

9 0.3570 0.14%

10 0.3581 0.45%

11 0.3591 0.73%

12 0.3624 1.65%

13 0.3600 0.98%

14 0.3575 0.28%

15 0.3620 1.54%

16 0.3595 0.84%

17 0.3600 0.98%

18 0.3615 1.40%

19 0.3585 0.56%

20 0.3571 0.17%

SHOW ALL YOUR SOLUTION BELOW.

Total weight of 20 tablets= 7.129

 Average weight = Total weight of 20 tablets
20 tablets
= 0.3565

STATISTICAL QUALITY CONTROL DATA SHEET

B. STATISTICAL QUALITY CONTROL

Tablet No. X (g) (X - x̄) (X - x̄)2

1 0.3633 0.0068 4.624 x 10-5

2 0.3609 0.0044 1.936 x 10-5

3 0.3622 0.0057 3.249 x 10-5

4 0.3589 0.0024 5.76 x 10-6

5 0.3590 0.0025 6.25 x 10-6

6 0.3584 0.0019 3.61 x 10-6

7 0.3573 0.0008 6.4 x 10-7

8 0.3593 0.0028 7.84 x 10-6

9 0.3570 0.0005 2.5 x 10-7

 10 0.3581 0.0016 2.56 x 10-6

11 0.3591 0.0026 6.76 x 10-6

12 0.3624 0.0059 3.481 x 10-5

13 0.3600 0.0035 1.225 x 10-5

14 0.3575 0.0010 1 x 10-6

15 0.3620 0.0055 3.025 x 10-5

16 0.3595 0.0030 9 x 10-6

17 0.3600 0.0035 1.225 x 10-5

18 0.3615 0.0050 2.5 x 10-5

19 0.3585 0.0020 4 x 10-6

20 0.3571 0.0006 3.6 x 10-7

Ʃ(X) = 7.129 Ʃ(X - x̄)= 0.062 Ʃ(X - x̄)2 = 2.6068 x 10-4

SHOW ALL YOUR SOLUTION BELOW.

● Calculate the mean, d, RAD, SD, RSD, R, UCL and LCL.
● Plot the graph and identify the average weight, UCL and LCL.
● Interpret the result shown in the graph to determine if the batch of sample tablets is in compliance with
the USP or not.
 The graph shows that there are samples go beyond the line of UCL which is 0.3600. In the graph, you can see also
that the mean is in the lower part of the graph. And the samples do not comply with the USP.

CONCLUSION
To conclude, the samples do not meet the standards of the USP because the data shows that there
are defects in the quality of the drugs. And I learned that in order to meet the expectations of your customer
you must use the method of quality control to ensure the safety and quality of your product.

REFERENCES
https://drive.google.com/drive/folders/1gej7rYyRHt9HgaZE9grne7FJqoNFRnwn