Module 1: WEIGHT VARIATION TESTS AND SQC OF CAPSULES AND TABLETS Flashcards
Defined as the degree of uniformity in the amount of drug substance among dosage units
Uniformity of Dosage Units
Consistency
Uniformity of Dosage Units
Difference
Weight Variation
USP Requirement for Weight
Variation Test for Capsules
πππ ππππ’πππππππ‘π πππ πππ‘ ππ π¬π¨πͺπ―
Within the USP limit
90% to 110%
Weight of the product
Weight Variation
Active drug substance/s
Content Uniformity
ππππ π formula
ππππ π =
βπ
ββ
π
βsum or totalβ
sigma
% π€πππβπ‘ π£πππππ‘πππ formula
% π€πππβπ‘ π£πππππ‘πππ =
π
βββ- π₯ 100
π βbarβ
βbarβ
Average
Used if applied to follow-up calculation
πΆππππ’πππ‘ππ ππ
Weight Variation Test for Tablets formula
% π€πππβπ‘ π£πππππ‘πππ =
/π β π βbarβ/
ββββββ π₯ 100
π βbarβ
π stands for
π πππππ π€πππβπ‘
π stands for
ππ’ππππ ππ π ππππππ
/π β π βbarβ/
β> the bracket mean?
Absolute value
(positive value)
Final answer
π πππππ‘ππ ππ
USP Requirement for Weight
Variation Test for Tablets
πΌπΊπ· ππππππππππππ πππ πππ ππ:
a. The weight of not more than two (0 to 2) of the tablets differ from the average weight by more than the percentage listed in the USP, and
b. No tablet differ by more than double that percentage.
Average weight of tablet (mg):
<130
% weight variation
> ?
> ?
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
% weight variation
> 10%
> 20%
Average weight of tablet (mg):
130 β 324
% weight variation
> ?
> ?
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
% weight variation
> 7.5%
> 15%
Average weight of tablet (mg):
>324
% weight variation
> ?
> ?
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
% weight variation
> 5%
> 10%
Average weight of tablet (mg):
> ?
% weight variation
> 10%
> 20%
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
Average weight of tablet (mg):
<130
Average weight of tablet (mg):
> ?
% weight variation
> 7.5%
> 15%
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
Average weight of tablet (mg):
130 β 324
Average weight of tablet (mg):
> ?
% weight variation
> 5%
> 10%
Number of Tablets (N=20)
> Minimum 18
> Maximum 2
Average weight of tablet (mg):
>324
STATISTICAL QUALITY CONTROL
ππππ π βbarβ formula
ππππ π =
π
STATISTICAL QUALITY CONTROL
ππ‘ππππππ π·ππ£πππ‘πππ (π ) formula
ππ‘ππππππ π·ππ£πππ‘πππ π =
square root of:
π β 1
STATISTICAL QUALITY CONTROL
π£πππππππ (π ^2) formula
π£πππππππ (π ^2) =
π β 1
STATISTICAL QUALITY CONTROL
* Upper Control Limit (UCL) Formula
ππΆπΏ = π βbarβ+ 3π
STATISTICAL QUALITY CONTROL
* Lower Control Limit (LCL) Formula
πΏπΆπΏ = π βbarβ β 3π
directly square the
βdisplayed valueβ
means of visualizing variations that occur in the central tendency and dispersion of a set of observations
Control Charts
used to study how a process changes over time
Control Charts
Control Charts Composed of:
β Central Line
β Upper Line for the UCL
β Lower Line for the LCL
Control Charts Can conclude if variation is
β CONSISTENT (in-control)
β UNPREDICTABLE (out of control)
How to Construct a Control Chart
- Determine the mean, UCL and LCL.
- Estimate an arbitrary range (with same interval).
- Draw the lines.
- Plot the data.
β Number of sample (X-axis)
β Sample Weight (Y-axis) - Interpret the results.
β Out-of-control signals
Plot the data.
- Number of sample
X-axis
Plot the data.
- Sample Weight
- UCL & LCL
Y-axis
Interpret the results
Out-of-control signals
Maximum (Ceiling)
Upper control limit
Minimum (Base)
Lower control limit
Arbitrary range
Interval