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Calculation of Acceptance Value

The document describes how to calculate the acceptance value for a drug product batch. It defines key terms like mean, standard deviation, acceptance value, and provides the formula to calculate acceptance value based on the sample size, mean content, and standard deviation. It also lists different reference values and maximum acceptance values that would apply depending on whether the mean content is within or outside certain ranges.

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Jai Murugesh
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356 views2 pages

Calculation of Acceptance Value

The document describes how to calculate the acceptance value for a drug product batch. It defines key terms like mean, standard deviation, acceptance value, and provides the formula to calculate acceptance value based on the sample size, mean content, and standard deviation. It also lists different reference values and maximum acceptance values that would apply depending on whether the mean content is within or outside certain ranges.

Uploaded by

Jai Murugesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Calculation of Acceptance Value

Calculate the acceptance value by the formula:

in which the terms are as defined in Table 2.


Table 2

Variable Definition Conditions Value

Mean of individual    
contents (χ 1, χ 2, …, χ n),
expressed as a percentage
X of the label claim

χ 1, χ 2, …, χ Individual contents of the    


n units tested, expressed as
a percentage of the label
claim

n Sample size (number of    


units in a sample)

k Acceptability constant If n = 10, then k 2.4


=

If n = 30, then k 2.0


=

s Sample standard deviation  

RSD Relative standard   100s/X


deviation (the sample
standard deviation
expressed as a percentage
of the mean)

M (case 1) Reference value If 98.5% ≤ X


to be ≤101.5%, then M = X (AV = ks)
applied
when If X <98.5%, M = 98.5%
T ≤101.5 then (AV = 98.5 – X + ks)

If X >101.5%, M = 101.5%
Variable Definition Conditions Value

then (AV = X – 101.5 + ks)

M (case 2) Reference value If 98.5 ≤ X ≤T, M=X


to be then (AV = ks)
applied
when If X <98.5%, M = 98.5%
T >101.5 then (AV = 98.5 – X + ks)

M = T%
If X >T, then (AV = X – T + ks)

Acceptance     General formula:


value (AV)

(Calculations are specified


above for the different
cases.)

L1 Maximum allowed   L1 = 15.0 unless otherwise


acceptance value specified

L2 Maximum allowed range On the low side, L2 = 25.0 unless otherwise


for deviation of each no dosage unit specified
dosage unit tested from result can be less
the calculated value of M than [1–
(0.01)(L2)]M,
while on the high
side, no dosage
unit result can be
greater than [1 +
(0.01)
(L2)]M. (This is
based on an L2
value of 25.0.)

T Target content per dosage


unit at the time of
manufacture, expressed as
a percentage of the label
claim. Unless otherwise
stated, T is 100.0%, or T
is the manufacturer's
approved target content
per dosage unit.

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