Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Quality Control Lab > Module 1: WEIGHT VARIATION TESTS AND SQC OF CAPSULES AND TABLETS > Flashcards

Module 1: WEIGHT VARIATION TESTS AND SQC OF CAPSULES AND TABLETS Flashcards

1
Q

Defined as the degree of uniformity in the amount of drug substance among dosage units

A

Uniformity of Dosage Units

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Consistency

A

Uniformity of Dosage Units

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Difference

A

Weight Variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

USP Requirement for Weight
Variation Test for Capsules
π‘ˆπ‘†π‘ƒ π‘Ÿπ‘’π‘žπ‘’π‘–π‘Ÿπ‘’π‘šπ‘’π‘›π‘‘π‘  π‘Žπ‘Ÿπ‘’ π‘šπ‘’π‘‘ 𝑖𝑓 𝑬𝑨π‘ͺ𝑯

Within the USP limit

A

90% to 110%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Weight of the product

A

Weight Variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Active drug substance/s

A

Content Uniformity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

π‘€π‘’π‘Žπ‘› 𝑋 formula

A

π‘€π‘’π‘Žπ‘› 𝑋 =
βˆ‘π‘‹
—–
𝑁

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

β€œsum or total”

A

sigma

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

% π‘€π‘’π‘–π‘”β„Žπ‘‘ π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘‘π‘–π‘œπ‘› formula

A

% π‘€π‘’π‘–π‘”β„Žπ‘‘ π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘‘π‘–π‘œπ‘› =
𝑋
β€”β€”β€”- π‘₯ 100
𝑋 β€˜bar’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

β€œbarβ€œ

A

Average

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Used if applied to follow-up calculation

A

πΆπ‘Žπ‘™π‘π‘’π‘™π‘Žπ‘‘π‘’π‘‘ π‘Žπ‘ 

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Weight Variation Test for Tablets formula

A

% π‘€π‘’π‘–π‘”β„Žπ‘‘ π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘‘π‘–π‘œπ‘› =

/𝑋 βˆ’ 𝑋 β€˜bar’/
β€”β€”β€”β€”β€”β€” π‘₯ 100
𝑋 β€˜bar’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

𝑋 stands for

A

π‘ π‘Žπ‘šπ‘π‘™π‘’ π‘€π‘’π‘–π‘”β„Žπ‘‘

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

𝑁 stands for

A

π‘›π‘’π‘šπ‘π‘’π‘Ÿ π‘œπ‘“ π‘ π‘Žπ‘šπ‘π‘™π‘’π‘ 

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

/𝑋 βˆ’ 𝑋 β€˜bar’/
–> the bracket mean?

A

Absolute value
(positive value)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Final answer

A

π‘…π‘’π‘π‘œπ‘Ÿπ‘‘π‘’π‘‘ π‘Žπ‘ 

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

USP Requirement for Weight
Variation Test for Tablets
𝑼𝑺𝑷 π’“π’†π’’π’–π’Šπ’“π’†π’Žπ’†π’π’•π’” 𝒂𝒓𝒆 π’Žπ’†π’• π’Šπ’‡:

A

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.

10
Q

Average weight of tablet (mg):
<130

% weight variation
> ?
> ?

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

% weight variation
> 10%
> 20%

11
Q

Average weight of tablet (mg):
130 – 324

% weight variation
> ?
> ?

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

% weight variation
> 7.5%
> 15%

12
Q

Average weight of tablet (mg):
>324

% weight variation
> ?
> ?

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

% weight variation
> 5%
> 10%

13
Q

Average weight of tablet (mg):
> ?

% weight variation
> 10%
> 20%

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

Average weight of tablet (mg):
<130

14
Q

Average weight of tablet (mg):
> ?

% weight variation
> 7.5%
> 15%

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

Average weight of tablet (mg):
130 – 324

15
Q

Average weight of tablet (mg):
> ?

% weight variation
> 5%
> 10%

Number of Tablets (N=20)
> Minimum 18
> Maximum 2

A

Average weight of tablet (mg):
>324

16
Q

STATISTICAL QUALITY CONTROL
π‘€π‘’π‘Žπ‘› 𝑋 β€˜bar’ formula

A

π‘€π‘’π‘Žπ‘› 𝑋 =

𝑁

17
Q

STATISTICAL QUALITY CONTROL
π‘†π‘‘π‘Žπ‘›π‘‘π‘Žπ‘Ÿπ‘‘ π·π‘’π‘£π‘–π‘Žπ‘‘π‘–π‘œπ‘› (𝑠) formula

A

π‘†π‘‘π‘Žπ‘›π‘‘π‘Žπ‘Ÿπ‘‘ π·π‘’π‘£π‘–π‘Žπ‘‘π‘–π‘œπ‘› 𝑠 =

square root of:

     𝑁 βˆ’ 1
18
Q

STATISTICAL QUALITY CONTROL
π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘›π‘π‘’ (𝑠^2) formula

A

π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘›π‘π‘’ (𝑠^2) =

      𝑁 βˆ’ 1
19
Q

STATISTICAL QUALITY CONTROL
* Upper Control Limit (UCL) Formula

A

π‘ˆπΆπΏ = 𝑋 β€˜bar’+ 3𝑠

20
Q

STATISTICAL QUALITY CONTROL
* Lower Control Limit (LCL) Formula

A

𝐿𝐢𝐿 = 𝑋 β€˜bar’ βˆ’ 3𝑠

21
Q

directly square the

A

β€œdisplayed value”

22
Q

means of visualizing variations that occur in the central tendency and dispersion of a set of observations

A

Control Charts

23
Q

used to study how a process changes over time

A

Control Charts

24
Q

Control Charts Composed of:

A

– Central Line
– Upper Line for the UCL
– Lower Line for the LCL

25
Q

Control Charts Can conclude if variation is

A

– CONSISTENT (in-control)
– UNPREDICTABLE (out of control)

26
Q

How to Construct a Control Chart

A
  • Determine the mean, UCL and LCL.
  • Estimate an arbitrary range (with same interval).
  • Draw the lines.
  • Plot the data.
    – Number of sample (X-axis)
    – Sample Weight (Y-axis)
  • Interpret the results.
    – Out-of-control signals
27
Q

Plot the data.
- Number of sample

A

X-axis

28
Q

Plot the data.
- Sample Weight
- UCL & LCL

A

Y-axis

29
Q

Interpret the results

A

Out-of-control signals

30
Q

Maximum (Ceiling)

A

Upper control limit

31
Q

Minimum (Base)

A

Lower control limit

32
Q

Arbitrary range

A

Interval

Quality Control Lab (5 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions