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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

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2
Q

Consistency

A

Uniformity of Dosage Units

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3
Q

Difference

A

Weight Variation

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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%

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4
Q

Weight of the product

A

Weight Variation

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5
Q

Active drug substance/s

A

Content Uniformity

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5
Q

π‘€π‘’π‘Žπ‘› 𝑋 formula

A

π‘€π‘’π‘Žπ‘› 𝑋 =
βˆ‘π‘‹
—–
𝑁

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6
Q

β€œsum or total”

A

sigma

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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’

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7
Q

β€œbarβ€œ

A

Average

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7
Q

Used if applied to follow-up calculation

A

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

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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’

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8
Q

𝑋 stands for

A

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

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9
Q

𝑁 stands for

A

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

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10
Q

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

A

Absolute value
(positive value)

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10
Q

Final answer

A

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

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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
STATISTICAL QUALITY CONTROL π‘†π‘‘π‘Žπ‘›π‘‘π‘Žπ‘Ÿπ‘‘ π·π‘’π‘£π‘–π‘Žπ‘‘π‘–π‘œπ‘› (𝑠) formula
π‘†π‘‘π‘Žπ‘›π‘‘π‘Žπ‘Ÿπ‘‘ π·π‘’π‘£π‘–π‘Žπ‘‘π‘–π‘œπ‘› 𝑠 = square root of: βˆ‘(𝑋 βˆ’ 𝑋 'bar')^2 ----------------------- 𝑁 βˆ’ 1
18
STATISTICAL QUALITY CONTROL π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘›π‘π‘’ (𝑠^2) formula
π‘£π‘Žπ‘Ÿπ‘–π‘Žπ‘›π‘π‘’ (𝑠^2) = βˆ‘(𝑋 βˆ’ 𝑋 'bar')^2 ------------------------ 𝑁 βˆ’ 1
19
STATISTICAL QUALITY CONTROL * Upper Control Limit (UCL) Formula
π‘ˆπΆπΏ = 𝑋 'bar'+ 3𝑠
20
STATISTICAL QUALITY CONTROL * Lower Control Limit (LCL) Formula
𝐿𝐢𝐿 = 𝑋 'bar' βˆ’ 3𝑠
21
directly square the
β€œdisplayed value”
22
means of visualizing variations that occur in the central tendency and dispersion of a set of observations
Control Charts
23
used to study how a process changes over time
Control Charts
24
Control Charts Composed of:
– Central Line – Upper Line for the UCL – Lower Line for the LCL
25
Control Charts Can conclude if variation is
– CONSISTENT (in-control) – UNPREDICTABLE (out of control)
26
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. – Number of sample (X-axis) – Sample Weight (Y-axis) * Interpret the results. – Out-of-control signals
27
Plot the data. - Number of sample
X-axis
28
Plot the data. - Sample Weight - UCL & LCL
Y-axis
29
Interpret the results
Out-of-control signals
30
Maximum (Ceiling)
Upper control limit
31
Minimum (Base)
Lower control limit
32
Arbitrary range
Interval

Quality Control Lab (5 decks)

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