Uniformity of
Weight of Tablets And Capsules
OBJEKTIF
i. To
determine the percentage deviation of tablets and capsules.
ii. To determine the uniformity of weight of tablets and capsules.
THEORY
The weight uniformity test is used to ensure that every tablet contains the
amount of drug substance intended with little variation among tablets within a
batch. Due to increased awareness of physiological availability, the weight
uniformity test has been included in the monographs of all tablets and all
capsules intended for oral administration where the range of size of the dosage
form available include 50mg or smaller sizes. Tablet monographs with a weight uniformity
requirement do not have weight variation requirements. Furthermore, the
uniformity of weight of tablets and capsule indicate the quality control of
specific batch of tablets and capsules.
I. MATERIALS AND APPARATUS
20 tablets, 20 capsules, electronic balance.
II. PROCEDURES
Tablets:
1. 20 selected tablets were weighted previously. The average weight was
determined.
2. Tablets were weighted and individually for each tablet, the percentage
deviation of it’s weight from average weight was determined.
3. The deviation of individual eight from average weight should not exceed the
limits given below.
Capsules:
1. 20 capsules were selected at random.
2. One capsule was weighted. Capsule was opened and the contents were removed
as completely as possible. The emptied shells were weighted. The net weight of
it’s contents was determined, that is by
substracting the weight of the shells from the weight of the intact capsule.
3. The procedure was repeated with other 19 capsules.
4. The average net weight was determined from the sum of the individual net
weights.
5. The percentage deviation was determined from the average net weight for each
capsule. The deviation of individual net weight should not exceed the limits
given below.
RESULTS
Tablets
Average weight: 13.1717g
The average net weight: 0.6586g
Tablets
|
The weight of individual tablets/g
|
The percentage deviation/ %
|
1
|
0.6563
|
-0.35
|
2
|
0.6636
|
+0.76
|
3
|
0.6625
|
+0.59
|
4
|
0.6587
|
+0.02
|
5
|
0.6601
|
+0.23
|
6
|
0.6638
|
+0.79
|
7
|
0.6577
|
-0.14
|
8
|
0.6696
|
+1.67
|
9
|
0.6570
|
-0.24
|
10
|
0.6587
|
+0.02
|
11
|
0.6427
|
-2.41
|
12
|
0.6561
|
-0.38
|
13
|
0.6423
|
-2.47
|
14
|
0.6554
|
-0.49
|
15
|
0.6551
|
-0.53
|
16
|
0.6630
|
+0.67
|
17
|
0.6595
|
+0.14
|
18
|
0.6575
|
-0.17
|
19
|
0.6746
|
+2.43
|
20
|
0.6575
|
-0.17
|
Capsules
Average weight: 7.1979g
The average net weight: 0.3599g
Capsules
|
The weight of capsules/ g
|
The weight of the shell only/ g
|
The weight of the contents/ g
|
The percentage deviation/ %
|
1
|
0.3562
|
0.0619
|
0.2943
|
-1.03
|
2
|
0.3634
|
0.0624
|
0.3010
|
+0.97
|
3
|
0.3535
|
0.0618
|
0.2917
|
-1.78
|
4
|
0.3717
|
0.0621
|
0.3096
|
+3.28
|
5
|
0.3570
|
0.0616
|
0.2954
|
-0.81
|
6
|
0.3554
|
0.0632
|
0.2922
|
-1.25
|
7
|
0.3521
|
0.0626
|
0.2895
|
-2.17
|
8
|
0.3464
|
0.0616
|
0.2848
|
-3.75
|
9
|
0.3616
|
0.0649
|
0.2967
|
-0.47
|
10
|
0.3696
|
0.0618
|
0.3078
|
+2.70
|
11
|
0.3678
|
0.0678
|
0.3000
|
+2.20
|
12
|
0.3694
|
0.0643
|
0.3051
|
+2.64
|
13
|
0.3511
|
0.0643
|
0.2868
|
-2.45
|
14
|
0.3558
|
0.0601
|
0.2957
|
-1.14
|
15
|
0.3643
|
0.0641
|
0.3002
|
+1.22
|
16
|
0.3625
|
0.0631
|
0.2994
|
+0.72
|
17
|
0.3764
|
0.0626
|
0.3138
|
+4.58
|
18
|
0.3627
|
0.0636
|
0.2991
|
+0.78
|
19
|
0.3612
|
0.0609
|
0.3003
|
+0.36
|
20
|
0.3475
|
0.0602
|
0.2873
|
-3.45
|
From the experiment, the equation below is used to calculate the percentage of
deviation of both tablets and capsules.
(experimental weight – theoretical weight)
x 100%
theoritical weight
For the tablets, the average weight for each tablet is 0.6586g which is much
lesser than 80mg. So, the percentage of deviation of individual weight from the
average weight should not exceed plus minus 10.0 % for minimum 18 tablets while
plus minus 20.0% for maximum 2 tablets. And the deviation of all tablets are
all in the range throughout the experiment. Hence, all tablets can be
considered as uniform in form of weight.
For the capsules, the average weight for each capsule is
0.3599g which is much lesser than 300mg. So, the percentage of deviation of
individual weight from the average weight should not exceed the limit plus
minus 10.0% for minimum 18 capsules while plus minus 20.0% for maximum 2
capsules. The percentage deviation of all the selected capsules are within the
range which is around plus minus 5.0%. So, the capsules are uniform in weight
and can be marketed.
CONCLUSION
For the tablets, the average weight is 13.1717g; the average net weight is
0.6586g; the range of percentage deviation is plus minus 3.0%.
For the capsules, the average weight is 7.1979g; the average net weight is
0.3599g; the range of percentage deviation is pus minus 5.0%.
So, all of the tablets and capsules are uniform in form of weight.
REFERENCE
i. Uniformity of
dosage units [Online]
Available from: http://www.pharmacopeia.cn/v29240/usp29nf24s0_c905.html
ii. Content
uniformity [Online]
iii. Quality
control tests for tablets [Online]
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