Content Uniformity and Dissolution Acceptance Limit Program

Version 2

Users guide
Written by James Bergum, Ph.D.
November 2nd, 2007
BEFORE YOU START:

The program and technical documentation is delivered on a compact disc (CD) AS-IS.
Although the author and validation team conducted a validation of the program, there is no
warranty as to the programs accuracy or use. Any use of the technical documentation of the
information contained therein is at the risk of the user. Documentation may include technical
or other inaccuracies or typographical errors.

This SAS™ program was written by a statistician and validated by other statisticians from
several other pharmaceutical companies. The programs and details of the validation are
contained on the CD. Companies may decide to perform additional validation.

In addition to information found in the validation files, the following articles contain details on
the method with examples. Note: Methods for content uniformity given in articles prior to the
2007 are not associated with the new USP test. Also, some of the methods used to construct
the confidence intervals given in the 1990 paper were revised in subsequent papers.

Bergum, J.S. (1990), Constructing Acceptance Limits for Multiple Stage Tests.
Drug Development and Industrial Pharmacy, 16(14), 2153-2166.

Bergum, J., Utter, M., Process Validation (2000), In: Shein-Chow, ed. Encyclopedia of
Biopharmaceutical Statistics, New York: Marcel Dekker, pp 422-439

Bergum, J.S. and Utter M.L. (2003), Statistical Methods for Uniformity and Dissolution
Testing. Pharmaceutical Process Validation edited by Robert A. Nash and Alfred H.
Watchter, New York: Marcel Dekker, pp.667-697.

Bergum, J., Li, H. (2007), Acceptance Limits for the New ICH USP 29 Content Uniformity
Test, Pharmaceutical Technology, October, pp 88-98.

OVERVIEW:

The content uniformity and dissolution acceptance limit program (CuDAL) is a set of
programs written by James Bergum in SAS™ that can be used to evaluate content uniformity
and dissolution data against the current USP 29 tests. Process validation and internal
release guides are examples of areas where the program has been applied. The program
can generate an acceptance limit table for content uniformity and/or dissolution that can be
applied to either of two sampling plans. The first sampling plan assumes that one unit is
tested for uniformity or dissolution from each of several locations throughout a batch. The
second sampling plan assumes that an equal number of units (greater than one) are tested
from several locations throughout a batch. For both sampling plans, the user can output the
acceptance limit table, perform an evaluation of the table that determines the probability of
passing the table given the population parameters, or generate a lower bound on the
probability of passing the uniformity or dissolution test for specific sample results. Meeting
the acceptance limits given in the table assures that any future sample taken from the batch
will pass the corresponding USP 29 content uniformity or dissolution test at least P% of the
time with a C% confidence level. The user provides the value of P and C.

The limits constructed and evaluated in these programs are based on the USP 29 tests for
dissolution and content uniformity for tablets and capsules (See Appendix for brief
descriptions of these tests). Acceptance limits and evaluations can be computed for either
content uniformity or dissolution. Since the acceptance limits depend on the sampling plan
used, there are four possible choices (2 methods by 2 sampling plans). The two sampling
plans are described below:
 Sampling Plan 1 assumes one dosage form is tested at each location. So in process
validation if one tablet were tested from each of 30 locations, this would follow sampling plan
1. Quality control samples generally are considered to follow sampling plan 1 since samples
are taken in short time intervals (ex every 10 minutes) throughout the manufacturing run and
composited. So, we assume that a random sample of the composite would result in one
dosage form per location. Sampling Plan 2 assumes that more than one dosage form is
taken at each location, which is common for process validation. The program assumes that
the same number of dosage forms is tested at each location. So, if 4 dosage forms were
tested at each of ten different locations during a manufacturing run, this would follow
sampling plan 2.

INSTALLATION:
The CD contains the following directories and files:

• Readme File: readme.txt

• Version 2 Users Guide: Users Guide.pdf

• Version 2 Validation Report: Version 2 Validation Report.pdf

• Directory: V2

o SAS Calculation Files:

ƒ CuDAL.SAS, Cusp1.SAS, Cusp2.SAS, Disp1.SAS, and Disp2.SAS

o SAS Navigation/Graphical Interface Files: cudal.sas7bcat and files.sas.org

• Directory: V1

ƒ All programs and validation materials for Version 1.

The programs for validation of version 1 are included since the dissolution calculations for version
2 did not change. The validation of the dissolution programs are contained in the V1
documentation. The remainder of this users guide only applies to Version 2.

The SAS™ programs were written in SAS™ Version 8.02 and will run on any IBM or compatible
PC that has SAS 8.02 or later on it. The Validation Report contains a validation summary, the
signed original protocol, amendments, final amended protocol with signed validation forms,
supporting documentation, and validation team curriculum vitas. To navigate the user’s guide or
validation report, use the navigation pane in Adobe Acrobat Reader. There are also many links
that can be used for navigation of these documents. The program can be run directly from the
CD (assuming the CD drive is D) or the files can be copied to a PC. If the CD drive is not labeled
D, then the file CuDAL.sas must be edited to provide the location of the files in the V2
subdirectory. The CuDAL.sas file is displayed below.
************* LIBRARY FOR THE APPLICATION******;
/* deleting the macro variables */
data vars;
set sashelp.vmacro;
run;
data _null_;
set vars;
if scope='GLOBAL' and name ^= 'SYSODSPATH' then
call execute('%symdel '||trim(left(name))||';');
run;

libname cudal 'D:\V2';

%global logoloc;
%let logoloc=D:\V2\cudal.jpeg;
options symbolgen mprint mlogic sasautos=('D:\V2');

dm 'af c=cudal.cudal.welcome.frame; ' continue;

There are three edits required if the program files in the directory V2 are copied from the CD to
another location or the drive letter for the CD is not D. Replace D:/V2 with the appropriate new
location. These edits are the only edits required to run the program. No other edits should be
made to these programs. [Note: When loading and running the CuDAL program, use a full
screen. If the screen is too small, some of the radio buttons may not appear]

USING THE PROGRAM:

To run the program load CuDAL.sas into the SAS™ editor window. After making any necessary
edits to the file locations (see above), submit the program. After submitting CuDAL.sas, the
following window will appear.
There are two options: Exit SAS or Enter the application. Click on the desired option.
If the option “Enter the Application” is selected, the following test/sampling plan selection screen
will appear.
There are four radio buttons that allow the user to select the desired test (content uniformity or
dissolution) and sampling plan (one dosage unit per location or multiple dosage units per
location). Select the desired button. Depending on the selected button, one of four different
windows will appear. Each of these windows and their sub-windows will be discussed separately
in the following sections.
Content Uniformity/Sampling Plan 1
If Content Uniformity/Sampling Plan 1 is selected, the following window appears:

The user enters the sample size (i.e., number of dosage units tested), the target (usually average
of potency limits (See USP test for more details), the coverage percentage (usually 90 or 95), and
the confidence level (usually 90 or 95). There are three choices for SAS output 1) The
acceptance limit table, 2) an evaluation of the acceptance limit table, and 3) a calculation of the
lower bound based on sample results. The user can pick more than one of these options. The
second option calculates the probability of passing the acceptance limit table based on the
sample size, coverage, and confidence level selected. The following table appears if this option
is selected.
The user provides “true” values for the population mean and coefficient of variation (CV) - also
called relative standard deviation (RSD) and then using these “true” values, the program
calculates the probability that the sample results will fall within the acceptance limits. The entries
on this window must all be integers. The lower bound, upper bound, increment, and divisor are
entered for both the desired population means and CV’s. The default values indicate that an
evaluation is performed using population means of 95.0 and 100.0 and CV’s of 1.0 and 4.0 since
the mean goes from 950 to 1000 by 50 and dividing by 10 (i.e., 950/10, then 1000/10) and the CV
goes from 10 to 40 by 30 (i.e., 10/10, then 40/10).

If the 3rd option - Lower Bound for Sample Result - is selected, then the following screen
appears:
The user enters the sample mean and sample CV.

Sample output from each of these three options are given on the following pages.
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY(N= 30, TARGET = 100.0)
SAMPLING PLAN 1
(MEETING LIMITS GUARANTEES, WITH 95.0% ASSURANCE, THAT AT LEAST
95.0% OF SAMPLES TESTED FOR CONTENT UNIFORMITY WILL PASS THE USP TEST)

MEAN CV MEAN CV MEAN CV MEAN CV MEAN CV MEAN CV

(% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%)

85.1 0.48 90.1 1.87 95.1 3.11 100.1 4.16 105.1 2.76 110.1 1.48
85.2 0.51 90.2 1.89 95.2 3.13 100.2 4.13 105.2 2.73 110.2 1.46
85.3 0.54 90.3 1.92 95.3 3.15 100.3 4.10 105.3 2.71 110.3 1.43
85.4 0.57 90.4 1.94 95.4 3.18 100.4 4.07 105.4 2.68 110.4 1.41
85.5 0.60 90.5 1.97 95.5 3.20 100.5 4.04 105.5 2.65 110.5 1.38
85.6 0.62 90.6 2.00 95.6 3.22 100.6 4.01 105.6 2.63 110.6 1.36
85.7 0.65 90.7 2.02 95.7 3.24 100.7 3.98 105.7 2.60 110.7 1.33
85.8 0.68 90.8 2.05 95.8 3.27 100.8 3.96 105.8 2.58 110.8 1.31
85.9 0.71 90.9 2.07 95.9 3.29 100.9 3.93 105.9 2.55 110.9 1.29
86.0 0.74 91.0 2.10 96.0 3.31 101.0 3.90 106.0 2.52 111.0 1.26
86.1 0.77 91.1 2.13 96.1 3.34 101.1 3.87 106.1 2.50 111.1 1.24
86.2 0.80 91.2 2.15 96.2 3.36 101.2 3.84 106.2 2.47 111.2 1.21
86.3 0.83 91.3 2.18 96.3 3.38 101.3 3.81 106.3 2.44 111.3 1.19
86.4 0.85 91.4 2.20 96.4 3.41 101.4 3.78 106.4 2.42 111.4 1.17
86.5 0.88 91.5 2.23 96.5 3.43 101.5 3.76 106.5 2.39 111.5 1.14
86.6 0.91 91.6 2.25 96.6 3.45 101.6 3.73 106.6 2.36 111.6 1.12
86.7 0.94 91.7 2.28 96.7 3.47 101.7 3.70 106.7 2.34 111.7 1.09
86.8 0.97 91.8 2.30 96.8 3.50 101.8 3.67 106.8 2.31 111.8 1.07
86.9 1.00 91.9 2.33 96.9 3.52 101.9 3.64 106.9 2.29 111.9 1.05
87.0 1.02 92.0 2.35 97.0 3.54 102.0 3.61 107.0 2.26 112.0 1.02
87.1 1.05 92.1 2.38 97.1 3.56 102.1 3.59 107.1 2.24 112.1 1.00
87.2 1.08 92.2 2.40 97.2 3.59 102.2 3.56 107.2 2.21 112.2 0.98
87.3 1.11 92.3 2.43 97.3 3.61 102.3 3.53 107.3 2.18 112.3 0.95
87.4 1.14 92.4 2.45 97.4 3.63 102.4 3.50 107.4 2.16 112.4 0.93
87.5 1.16 92.5 2.48 97.5 3.65 102.5 3.47 107.5 2.13 112.5 0.90
87.6 1.19 92.6 2.50 97.6 3.67 102.6 3.45 107.6 2.11 112.6 0.88
87.7 1.22 92.7 2.53 97.7 3.70 102.7 3.42 107.7 2.08 112.7 0.86
87.8 1.25 92.8 2.55 97.8 3.72 102.8 3.39 107.8 2.06 112.8 0.84
87.9 1.27 92.9 2.58 97.9 3.74 102.9 3.36 107.9 2.03 112.9 0.81
88.0 1.30 93.0 2.60 98.0 3.76 103.0 3.33 108.0 2.00 113.0 0.79
88.1 1.33 93.1 2.63 98.1 3.78 103.1 3.31 108.1 1.98 113.1 0.77
88.2 1.36 93.2 2.65 98.2 3.81 103.2 3.28 108.2 1.95 113.2 0.74
88.3 1.38 93.3 2.68 98.3 3.83 103.3 3.25 108.3 1.93 113.3 0.72
88.4 1.41 93.4 2.70 98.4 3.85 103.4 3.22 108.4 1.90 113.4 0.70
88.5 1.44 93.5 2.72 98.5 3.87 103.5 3.20 108.5 1.88 113.5 0.67
88.6 1.47 93.6 2.75 98.6 3.89 103.6 3.17 108.6 1.85 113.6 0.65
88.7 1.49 93.7 2.77 98.7 3.91 103.7 3.14 108.7 1.83 113.7 0.63
88.8 1.52 93.8 2.80 98.8 3.93 103.8 3.11 108.8 1.80 113.8 0.60
88.9 1.55 93.9 2.82 98.9 3.96 103.9 3.09 108.9 1.78 113.9 0.58
89.0 1.57 94.0 2.84 99.0 3.98 104.0 3.06 109.0 1.75 114.0 0.56
89.1 1.60 94.1 2.87 99.1 4.00 104.1 3.03 109.1 1.73 114.1 0.54
89.2 1.63 94.2 2.89 99.2 4.02 104.2 3.00 109.2 1.70 114.2 0.51
89.3 1.65 94.3 2.92 99.3 4.04 104.3 2.98 109.3 1.68 114.3 0.49
89.4 1.68 94.4 2.94 99.4 4.06 104.4 2.95 109.4 1.65 114.4 0.47
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY(N= 30, TARGET = 100.0)
SAMPLING PLAN 1
(MEETING LIMITS GUARANTEES, WITH 95.0% ASSURANCE, THAT AT LEAST
95.0% OF SAMPLES TESTED FOR CONTENT UNIFORMITY WILL PASS THE USP TEST)

MEAN CV MEAN CV MEAN CV MEAN CV MEAN CV MEAN CV

(% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%)

89.5 1.71 94.5 2.96 99.5 4.08 104.5 2.92 109.5 1.63 114.5 0.44
89.6 1.73 94.6 2.99 99.6 4.10 104.6 2.90 109.6 1.60 114.6 0.42
89.7 1.76 94.7 3.01 99.7 4.12 104.7 2.87 109.7 1.58 114.7 0.40
89.8 1.79 94.8 3.03 99.8 4.14 104.8 2.84 109.8 1.55 114.8 0.38
89.9 1.81 94.9 3.06 99.9 4.16 104.9 2.82 109.9 1.53 114.9 0.35
90.0 1.84 95.0 3.08 100.0 4.18 105.0 2.79 110.0 1.50
 ACCEPTANCE LIMIT TABLE FOR CONTENT UNIFORMITY(N= 30)
SAMPLING PLAN 1
DETERMINE PROBABILITY OF PASSING ACCEPTANCE LIMIT TABLE
CONFIDENCE LEVEL = 95.0 AND LOWER BOUND = 95.0

PROBABILITY
OF
U CV PASSING

95 1 1.00000
100 1 1.00000
95 4 0.05220
100 4 0.56434
 ACCEPTANCE LIMIT TABLE FOR CONTENT UNIFORMITY(N= 30)
SAMPLING PLAN 1
DETERMINE PROBABILITY OF FUTURE SAMPLES PASSING THE USP TEST
WITH 95.0 ASSURANCE FOR GIVEN SAMPLE MEAN AND CV

SAMPLE SAMPLE
MEAN STD DEV LOWER
(% CLAIM) (% CLAIM) CV BOUND

100 4 4 0.98003
Content Uniformity/Sampling Plan 2

If Content Uniformity/Sampling Plan 2 is selected, the following screen appears:

The user enters the number of locations, the number of dosage units per location, target, the
coverage probability, and the confidence level. There are three choices for SAS output 1) The
acceptance limit table, 2) an evaluation of the acceptance limit table, and 3) a calculation of the
lower bound based on sample results. The user can pick more than one of these options. The
second option calculates the probability of passing the acceptance limit table based on the
sample size, coverage, and confidence level selected. The following table appears if this option
is selected.
The user provides “true” values for the population mean, coefficient of variation (CV) within
locations, and CV for the between location. Using these “true” values, the program calculates the
probability that the sample results will fall within the acceptance limits. The entries on this
window must all be integers. The lower bound, upper bound, increment, and divisor are entered
for both the desired population means and within/between location CV’s. The default values
indicate that an evaluation is performed using population means of 95.0 and 100.0, within location
CV of 2.2, and between location CV’ of 2.2 since the mean goes from 950 to 1000 by 50 and
dividing by 10 (i.e., 950/10, then 1000/10) and the CV’s go from 22 to 22 by 10 (i.e., only one
value - 22/10).

If the 3rd option - Lower Bound for Sample Result - is selected, then the following screen
appears:
The user enters the sample mean, within sample standard deviation, and between sample
standard deviation [Note: This is just the sample standard deviation of the sample means, not a
variance component!]

Sample output from each of these three options are given on the following pages.
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

0.1 84.8 115.2 84.8 115.2 85.3 114.7 85.9 114.1 86.5 113.5 87.1 112.9 87.7 112.3 88.3 111.7 88.8 111.2
0.2 84.7 115.3 84.8 115.2 85.4 114.6 86.0 114.0 86.5 113.5 87.1 112.9 87.7 112.3 88.3 111.7 88.9 111.1
0.3 84.6 115.4 85.0 115.0 85.5 114.5 86.0 114.0 86.6 113.4 87.2 112.8 87.7 112.3 88.3 111.7 88.9 111.1
0.4 84.9 115.1 85.2 114.8 85.6 114.4 86.1 113.9 86.7 113.3 87.2 112.8 87.8 112.2 88.4 111.6 88.9 111.1
0.5 85.2 114.8 85.4 114.6 85.8 114.2 86.2 113.8 86.8 113.2 87.3 112.7 87.8 112.2 88.4 111.6 89.0 111.0
0.6 85.4 114.6 85.7 114.3 86.0 114.0 86.4 113.6 86.9 113.1 87.4 112.6 87.9 112.1 88.5 111.5 89.0 111.0
0.7 85.7 114.3 85.9 114.1 86.2 113.8 86.6 113.4 87.0 113.0 87.5 112.5 88.0 112.0 88.6 111.4 89.1 110.9
0.8 86.0 114.0 86.2 113.8 86.5 113.5 86.8 113.2 87.2 112.8 87.7 112.3 88.2 111.8 88.7 111.3 89.2 110.8
0.9 86.3 113.7 86.5 113.5 86.7 113.3 87.0 113.0 87.4 112.6 87.8 112.2 88.3 111.7 88.8 111.2 89.3 110.7
1.0 86.6 113.4 86.8 113.2 87.0 113.0 87.3 112.7 87.6 112.4 88.0 112.0 88.4 111.6 88.9 111.1 89.4 110.6
1.1 86.9 113.1 87.1 112.9 87.3 112.7 87.5 112.5 87.8 112.2 88.2 111.8 88.6 111.4 89.1 110.9 89.6 110.4
1.2 87.2 112.8 87.3 112.7 87.5 112.5 87.8 112.2 88.1 111.9 88.4 111.6 88.8 111.2 89.2 110.8 89.7 110.3
1.3 87.5 112.5 87.6 112.4 87.8 112.2 88.0 112.0 88.3 111.7 88.6 111.4 89.0 111.0 89.4 110.6 89.9 110.1
1.4 87.8 112.2 87.9 112.1 88.1 111.9 88.3 111.7 88.6 111.4 88.9 111.1 89.2 110.8 89.6 110.4 90.0 110.0
1.5 88.0 112.0 88.2 111.8 88.4 111.6 88.6 111.4 88.8 111.2 89.1 110.9 89.4 110.6 89.8 110.2 90.2 109.8
1.6 88.3 111.7 88.5 111.5 88.7 111.3 88.9 111.1 89.1 110.9 89.4 110.6 89.7 110.3 90.0 110.0 90.4 109.6
1.7 88.6 111.4 88.8 111.2 88.9 111.1 89.1 110.9 89.4 110.6 89.6 110.4 89.9 110.1 90.2 109.8 90.6 109.4
1.8 88.9 111.1 89.1 110.9 89.2 110.8 89.4 110.6 89.6 110.4 89.9 110.1 90.2 109.8 90.5 109.5 90.8 109.2
1.9 89.2 110.8 89.4 110.6 89.5 110.5 89.7 110.3 89.9 110.1 90.1 109.9 90.4 109.6 90.7 109.3 91.0 109.0
2.0 89.5 110.5 89.6 110.4 89.8 110.2 90.0 110.0 90.2 109.8 90.4 109.6 90.7 109.3 91.0 109.0 91.3 108.7
2.1 89.8 110.2 89.9 110.1 90.1 109.9 90.3 109.7 90.5 109.5 90.7 109.3 90.9 109.1 91.2 108.8 91.5 108.5
2.2 90.1 109.9 90.2 109.8 90.4 109.6 90.6 109.4 90.7 109.3 91.0 109.0 91.2 108.8 91.5 108.5 91.8 108.2
2.3 90.4 109.6 90.5 109.5 90.7 109.3 90.8 109.2 91.0 109.0 91.2 108.8 91.5 108.5 91.7 108.3 92.0 108.0
2.4 90.7 109.3 90.8 109.2 91.0 109.0 91.1 108.9 91.3 108.7 91.5 108.5 91.7 108.3 92.0 108.0 92.3 107.7
2.5 91.0 109.0 91.1 108.9 91.2 108.8 91.4 108.6 91.6 108.4 91.8 108.2 92.0 108.0 92.2 107.8 92.5 107.5
2.6 91.2 108.8 91.4 108.6 91.5 108.5 91.7 108.3 91.9 108.1 92.1 107.9 92.3 107.7 92.5 107.5 92.8 107.2
2.7 91.5 108.5 91.7 108.3 91.8 108.2 92.0 108.0 92.2 107.8 92.4 107.6 92.6 107.4 92.8 107.2 93.0 107.0
2.8 91.8 108.2 92.0 108.0 92.1 107.9 92.3 107.7 92.4 107.6 92.6 107.4 92.8 107.2 93.1 106.9 93.3 106.7
2.9 92.1 107.9 92.3 107.7 92.4 107.6 92.6 107.4 92.7 107.3 92.9 107.1 93.1 106.9 93.3 106.7 93.6 106.4
3.0 92.4 107.6 92.5 107.5 92.7 107.3 92.9 107.1 93.0 107.0 93.2 106.8 93.4 106.6 93.6 106.4 93.8 106.2
3.1 92.7 107.3 92.8 107.2 93.0 107.0 93.1 106.9 93.3 106.7 93.5 106.5 93.7 106.3 93.9 106.1 94.1 105.9
3.2 93.0 107.0 93.1 106.9 93.3 106.7 93.4 106.6 93.6 106.4 93.8 106.2 94.0 106.0 94.2 105.8 94.4 105.6
3.3 93.3 106.7 93.4 106.6 93.6 106.4 93.7 106.3 93.9 106.1 94.1 105.9 94.2 105.8 94.4 105.6 94.7 105.3
3.4 93.6 106.4 93.7 106.3 93.9 106.1 94.0 106.0 94.2 105.8 94.3 105.7 94.5 105.5 94.7 105.3 94.9 105.1
3.5 93.9 106.1 94.0 106.0 94.1 105.9 94.3 105.7 94.5 105.5 94.6 105.4 94.8 105.2 95.0 105.0 95.2 104.8
3.6 94.2 105.8 94.3 105.7 94.4 105.6 94.6 105.4 94.8 105.2 94.9 105.1 95.1 104.9 95.3 104.7 95.5 104.5
3.7 94.5 105.5 94.6 105.4 94.7 105.3 94.9 105.1 95.0 105.0 95.2 104.8 95.4 104.6 95.6 104.4 95.8 104.2
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

3.8 94.7 105.3 94.9 105.1 95.0 105.0 95.2 104.8 95.3 104.7 95.5 104.5 95.7 104.3 95.9 104.1 96.1 103.9
3.9 95.0 105.0 95.2 104.8 95.3 104.7 95.5 104.5 95.6 104.4 95.8 104.2 96.0 104.0 96.1 103.9 96.3 103.7
4.0 95.3 104.7 95.5 104.5 95.6 104.4 95.8 104.2 95.9 104.1 96.1 103.9 96.3 103.7 96.4 103.6 96.6 103.4
4.1 95.6 104.4 95.8 104.2 95.9 104.1 96.1 103.9 96.2 103.8 96.4 103.6 96.5 103.5 96.7 103.3 96.9 103.1
4.2 95.9 104.1 96.1 103.9 96.2 103.8 96.3 103.7 96.5 103.5 96.7 103.3 96.8 103.2 97.0 103.0 97.2 102.8
4.3 96.2 103.8 96.4 103.6 96.5 103.5 96.6 103.4 96.8 103.2 97.0 103.0 97.1 102.9 97.3 102.7 97.5 102.5
4.4 96.5 103.5 96.6 103.4 96.8 103.2 96.9 103.1 97.1 102.9 97.2 102.8 97.4 102.6 97.6 102.4 97.8 102.2
4.5 96.8 103.2 96.9 103.1 97.1 102.9 97.2 102.8 97.4 102.6 97.5 102.5 97.7 102.3 97.9 102.1 98.1 101.9
4.6 97.1 102.9 97.2 102.8 97.4 102.6 97.5 102.5 97.7 102.3 97.8 102.2 98.0 102.0 98.2 101.8 98.4 101.6
4.7 97.4 102.6 97.5 102.5 97.7 102.3 97.8 102.2 98.0 102.0 98.1 101.9 98.3 101.7 98.5 101.5 98.7 101.3
4.8 97.7 102.3 97.8 102.2 98.0 102.0 98.1 101.9 98.3 101.7 98.4 101.6 98.6 101.4 98.8 101.2 99.0 101.0
4.9 98.0 102.0 98.2 101.8 98.3 101.7 98.4 101.6 98.6 101.4 98.8 101.2 98.9 101.1 99.1 100.9 99.3 100.7
5.0 98.3 101.7 98.5 101.5 98.6 101.4 98.8 101.2 98.9 101.1 99.1 100.9 99.3 100.7 99.4 100.6 99.6 100.4
5.1 98.7 101.3 98.9 101.1 99.0 101.0 99.2 100.8 99.3 100.7 99.5 100.5 99.7 100.3 99.9 100.1
5.2 99.2 100.8 99.4 100.6 99.5 100.5 99.7 100.3 99.9 100.1
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

0.1 89.4 110.6 90.0 110.0 90.6 109.4 91.2 108.8 91.8 108.2 92.4 107.6 92.9 107.1 93.5 106.5 94.1 105.9
0.2 89.4 110.6 90.0 110.0 90.6 109.4 91.2 108.8 91.8 108.2 92.4 107.6 93.0 107.0 93.5 106.5 94.1 105.9
0.3 89.5 110.5 90.0 110.0 90.6 109.4 91.2 108.8 91.8 108.2 92.4 107.6 93.0 107.0 93.6 106.4 94.1 105.9
0.4 89.5 110.5 90.1 109.9 90.7 109.3 91.2 108.8 91.8 108.2 92.4 107.6 93.0 107.0 93.6 106.4 94.2 105.8
0.5 89.6 110.4 90.1 109.9 90.7 109.3 91.3 108.7 91.9 108.1 92.4 107.6 93.0 107.0 93.6 106.4 94.2 105.8
0.6 89.6 110.4 90.2 109.8 90.8 109.2 91.3 108.7 91.9 108.1 92.5 107.5 93.1 106.9 93.6 106.4 94.2 105.8
0.7 89.7 110.3 90.2 109.8 90.8 109.2 91.4 108.6 92.0 108.0 92.5 107.5 93.1 106.9 93.7 106.3 94.3 105.7
0.8 89.8 110.2 90.3 109.7 90.9 109.1 91.4 108.6 92.0 108.0 92.6 107.4 93.2 106.8 93.7 106.3 94.3 105.7
0.9 89.9 110.1 90.4 109.6 91.0 109.0 91.5 108.5 92.1 107.9 92.6 107.4 93.2 106.8 93.8 106.2 94.4 105.6
1.0 90.0 110.0 90.5 109.5 91.0 109.0 91.6 108.4 92.1 107.9 92.7 107.3 93.3 106.7 93.8 106.2 94.4 105.6
1.1 90.1 109.9 90.6 109.4 91.1 108.9 91.7 108.3 92.2 107.8 92.8 107.2 93.3 106.7 93.9 106.1 94.5 105.5
1.2 90.2 109.8 90.7 109.3 91.2 108.8 91.8 108.2 92.3 107.7 92.9 107.1 93.4 106.6 94.0 106.0 94.5 105.5
1.3 90.3 109.7 90.8 109.2 91.4 108.6 91.9 108.1 92.4 107.6 93.0 107.0 93.5 106.5 94.1 105.9 94.6 105.4
1.4 90.5 109.5 91.0 109.0 91.5 108.5 92.0 108.0 92.5 107.5 93.1 106.9 93.6 106.4 94.1 105.9 94.7 105.3
1.5 90.7 109.3 91.1 108.9 91.6 108.4 92.1 107.9 92.6 107.4 93.2 106.8 93.7 106.3 94.2 105.8 94.8 105.2
1.6 90.8 109.2 91.3 108.7 91.8 108.2 92.3 107.7 92.8 107.2 93.3 106.7 93.8 106.2 94.3 105.7 94.9 105.1
1.7 91.0 109.0 91.5 108.5 91.9 108.1 92.4 107.6 92.9 107.1 93.4 106.6 93.9 106.1 94.4 105.6 95.0 105.0
1.8 91.2 108.8 91.6 108.4 92.1 107.9 92.5 107.5 93.0 107.0 93.5 106.5 94.0 106.0 94.6 105.4 95.1 104.9
1.9 91.4 108.6 91.8 108.2 92.3 107.7 92.7 107.3 93.2 106.8 93.7 106.3 94.2 105.8 94.7 105.3 95.2 104.8
2.0 91.6 108.4 92.0 108.0 92.4 107.6 92.9 107.1 93.3 106.7 93.8 106.2 94.3 105.7 94.8 105.2 95.3 104.7
2.1 91.9 108.1 92.2 107.8 92.6 107.4 93.1 106.9 93.5 106.5 94.0 106.0 94.4 105.6 94.9 105.1 95.4 104.6
2.2 92.1 107.9 92.4 107.6 92.8 107.2 93.2 106.8 93.7 106.3 94.1 105.9 94.6 105.4 95.1 104.9 95.6 104.4
2.3 92.3 107.7 92.7 107.3 93.0 107.0 93.4 106.6 93.9 106.1 94.3 105.7 94.8 105.2 95.2 104.8 95.7 104.3
2.4 92.6 107.4 92.9 107.1 93.3 106.7 93.6 106.4 94.0 106.0 94.5 105.5 94.9 105.1 95.4 104.6 95.9 104.1
2.5 92.8 107.2 93.1 106.9 93.5 106.5 93.8 106.2 94.2 105.8 94.7 105.3 95.1 104.9 95.6 104.4 96.0 104.0
2.6 93.1 106.9 93.4 106.6 93.7 106.3 94.1 105.9 94.4 105.6 94.9 105.1 95.3 104.7 95.7 104.3 96.2 103.8
2.7 93.3 106.7 93.6 106.4 93.9 106.1 94.3 105.7 94.7 105.3 95.1 104.9 95.5 104.5 95.9 104.1 96.4 103.6
2.8 93.6 106.4 93.9 106.1 94.2 105.8 94.5 105.5 94.9 105.1 95.3 104.7 95.7 104.3 96.1 103.9 96.5 103.5
2.9 93.8 106.2 94.1 105.9 94.4 105.6 94.7 105.3 95.1 104.9 95.5 104.5 95.9 104.1 96.3 103.7 96.7 103.3
3.0 94.1 105.9 94.4 105.6 94.7 105.3 95.0 105.0 95.3 104.7 95.7 104.3 96.1 103.9 96.5 103.5 96.9 103.1
3.1 94.4 105.6 94.6 105.4 94.9 105.1 95.2 104.8 95.5 104.5 95.9 104.1 96.3 103.7 96.7 103.3 97.1 102.9
3.2 94.6 105.4 94.9 105.1 95.2 104.8 95.5 104.5 95.8 104.2 96.1 103.9 96.5 103.5 96.9 103.1 97.3 102.7
3.3 94.9 105.1 95.1 104.9 95.4 104.6 95.7 104.3 96.0 104.0 96.4 103.6 96.7 103.3 97.1 102.9 97.5 102.5
3.4 95.2 104.8 95.4 104.6 95.7 104.3 96.0 104.0 96.3 103.7 96.6 103.4 96.9 103.1 97.3 102.7 97.7 102.3
3.5 95.4 104.6 95.7 104.3 95.9 104.1 96.2 103.8 96.5 103.5 96.8 103.2 97.2 102.8 97.5 102.5 97.9 102.1
3.6 95.7 104.3 96.0 104.0 96.2 103.8 96.5 103.5 96.8 103.2 97.1 102.9 97.4 102.6 97.8 102.2 98.1 101.9
3.7 96.0 104.0 96.2 103.8 96.5 103.5 96.7 103.3 97.0 103.0 97.3 102.7 97.6 102.4 98.0 102.0 98.3 101.7
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

3.8 96.3 103.7 96.5 103.5 96.7 103.3 97.0 103.0 97.3 102.7 97.6 102.4 97.9 102.1 98.2 101.8 98.6 101.4
3.9 96.6 103.4 96.8 103.2 97.0 103.0 97.3 102.7 97.5 102.5 97.8 102.2 98.1 101.9 98.5 101.5 98.8 101.2
4.0 96.8 103.2 97.1 102.9 97.3 102.7 97.5 102.5 97.8 102.2 98.1 101.9 98.4 101.6 98.7 101.3 99.0 101.0
4.1 97.1 102.9 97.3 102.7 97.6 102.4 97.8 102.2 98.1 101.9 98.3 101.7 98.6 101.4 98.9 101.1 99.3 100.7
4.2 97.4 102.6 97.6 102.4 97.8 102.2 98.1 101.9 98.3 101.7 98.6 101.4 98.9 101.1 99.2 100.8 99.5 100.5
4.3 97.7 102.3 97.9 102.1 98.1 101.9 98.4 101.6 98.6 101.4 98.9 101.1 99.2 100.8 99.5 100.5 99.8 100.2
4.4 98.0 102.0 98.2 101.8 98.4 101.6 98.6 101.4 98.9 101.1 99.1 100.9 99.4 100.6 99.7 100.3 100.0 100.0
4.5 98.3 101.7 98.5 101.5 98.7 101.3 98.9 101.1 99.2 100.8 99.4 100.6 99.7 100.3 100.0 100.0
4.6 98.5 101.5 98.8 101.2 99.0 101.0 99.2 100.8 99.4 100.6 99.7 100.3 100.0 100.0
4.7 98.8 101.2 99.0 101.0 99.3 100.7 99.5 100.5 99.7 100.3 100.0 100.0
4.8 99.1 100.9 99.3 100.7 99.6 100.4 99.8 100.2 100.0 100.0
4.9 99.5 100.5 99.7 100.3 99.9 100.1
5.0 99.8 100.2 100.0 100.0
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

0.1 94.7 105.3 95.3 104.7 95.9 104.1 96.5 103.5 97.1 102.9 97.7 102.3 98.2 101.8 98.8 101.2 99.4 100.6
0.2 94.7 105.3 95.3 104.7 95.9 104.1 96.5 103.5 97.1 102.9 97.7 102.3 98.2 101.8 98.8 101.2 99.4 100.6
0.3 94.7 105.3 95.3 104.7 95.9 104.1 96.5 103.5 97.1 102.9 97.7 102.3 98.3 101.7 98.9 101.1 99.4 100.6
0.4 94.7 105.3 95.3 104.7 95.9 104.1 96.5 103.5 97.1 102.9 97.7 102.3 98.3 101.7 98.9 101.1 99.5 100.5
0.5 94.8 105.2 95.4 104.6 95.9 104.1 96.5 103.5 97.1 102.9 97.7 102.3 98.3 101.7 98.9 101.1 99.5 100.5
0.6 94.8 105.2 95.4 104.6 96.0 104.0 96.6 103.4 97.1 102.9 97.7 102.3 98.3 101.7 98.9 101.1 99.5 100.5
0.7 94.8 105.2 95.4 104.6 96.0 104.0 96.6 103.4 97.2 102.8 97.8 102.2 98.3 101.7 98.9 101.1 99.5 100.5
0.8 94.9 105.1 95.5 104.5 96.0 104.0 96.6 103.4 97.2 102.8 97.8 102.2 98.4 101.6 99.0 101.0 99.6 100.4
0.9 94.9 105.1 95.5 104.5 96.1 103.9 96.7 103.3 97.2 102.8 97.8 102.2 98.4 101.6 99.0 101.0 99.6 100.4
1.0 95.0 105.0 95.6 104.4 96.1 103.9 96.7 103.3 97.3 102.7 97.9 102.1 98.5 101.5 99.0 101.0 99.6 100.4
1.1 95.0 105.0 95.6 104.4 96.2 103.8 96.8 103.2 97.3 102.7 97.9 102.1 98.5 101.5 99.1 100.9 99.7 100.3
1.2 95.1 104.9 95.7 104.3 96.2 103.8 96.8 103.2 97.4 102.6 98.0 102.0 98.5 101.5 99.1 100.9 99.7 100.3
1.3 95.2 104.8 95.7 104.3 96.3 103.7 96.9 103.1 97.4 102.6 98.0 102.0 98.6 101.4 99.2 100.8 99.8 100.2
1.4 95.3 104.7 95.8 104.2 96.4 103.6 96.9 103.1 97.5 102.5 98.1 101.9 98.7 101.3 99.2 100.8 99.8 100.2
1.5 95.3 104.7 95.9 104.1 96.4 103.6 97.0 103.0 97.6 102.4 98.1 101.9 98.7 101.3 99.3 100.7 99.9 100.1
1.6 95.4 104.6 96.0 104.0 96.5 103.5 97.1 102.9 97.7 102.3 98.2 101.8 98.8 101.2 99.4 100.6 99.9 100.1
1.7 95.5 104.5 96.1 103.9 96.6 103.4 97.2 102.8 97.7 102.3 98.3 101.7 98.9 101.1 99.4 100.6 100.0 100.0
1.8 95.6 104.4 96.2 103.8 96.7 103.3 97.3 102.7 97.8 102.2 98.4 101.6 98.9 101.1 99.5 100.5
1.9 95.7 104.3 96.3 103.7 96.8 103.2 97.3 102.7 97.9 102.1 98.5 101.5 99.0 101.0 99.6 100.4
2.0 95.8 104.2 96.4 103.6 96.9 103.1 97.4 102.6 98.0 102.0 98.5 101.5 99.1 100.9 99.7 100.3
2.1 96.0 104.0 96.5 103.5 97.0 103.0 97.5 102.5 98.1 101.9 98.6 101.4 99.2 100.8 99.7 100.3
2.2 96.1 103.9 96.6 103.4 97.1 102.9 97.7 102.3 98.2 101.8 98.7 101.3 99.3 100.7 99.8 100.2
2.3 96.2 103.8 96.7 103.3 97.2 102.8 97.8 102.2 98.3 101.7 98.8 101.2 99.4 100.6 99.9 100.1
2.4 96.4 103.6 96.9 103.1 97.4 102.6 97.9 102.1 98.4 101.6 99.0 101.0 99.5 100.5 100.0 100.0
2.5 96.5 103.5 97.0 103.0 97.5 102.5 98.0 102.0 98.5 101.5 99.1 100.9 99.6 100.4
2.6 96.7 103.3 97.1 102.9 97.6 102.4 98.1 101.9 98.7 101.3 99.2 100.8 99.7 100.3
2.7 96.8 103.2 97.3 102.7 97.8 102.2 98.3 101.7 98.8 101.2 99.3 100.7 99.8 100.2
2.8 97.0 103.0 97.5 102.5 97.9 102.1 98.4 101.6 98.9 101.1 99.4 100.6 100.0 100.0
2.9 97.2 102.8 97.6 102.4 98.1 101.9 98.6 101.4 99.1 100.9 99.6 100.4
3.0 97.3 102.7 97.8 102.2 98.3 101.7 98.7 101.3 99.2 100.8 99.7 100.3
3.1 97.5 102.5 98.0 102.0 98.4 101.6 98.9 101.1 99.4 100.6 99.9 100.1
3.2 97.7 102.3 98.1 101.9 98.6 101.4 99.1 100.9 99.5 100.5 100.0 100.0
3.3 97.9 102.1 98.3 101.7 98.8 101.2 99.2 100.8 99.7 100.3
3.4 98.1 101.9 98.5 101.5 98.9 101.1 99.4 100.6 99.9 100.1
3.5 98.3 101.7 98.7 101.3 99.1 100.9 99.6 100.4 100.0 100.0
3.6 98.5 101.5 98.9 101.1 99.3 100.7 99.8 100.2
3.7 98.7 101.3 99.1 100.9 99.5 100.5 100.0 100.0
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

3.8 98.9 101.1 99.3 100.7 99.7 100.3

3.9 99.2 100.8 99.5 100.5 99.9 100.1
4.0 99.4 100.6 99.8 100.2
4.1 99.6 100.4 100.0 100.0
4.2 99.9 100.1
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
TARGET=100.0, LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER(LL) AND UPPER(UL) LIMITS ON THE MEAN
OF 40 ASSAYS- 4 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

2.8 2.9 3.0 3.1 3.2 3.3 3.4 3.5 3.6

SE LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL LL UL

0.1 100.0 100.0

0.2 100.0 100.0
0.3 100.0 100.0
0.4 100.0 100.0
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2
PROBABILITY OF PASSING ACCEPTANCE LIMIT TABLE
WITH 4 ASSAYS AT EACH OF 10 LOCATIONS
CONFIDENCE LEVEL = 95.0 & LOWER BOUND = 95.0

PROBABILITY
WITHIN LOCATION BETWEEN LOCATION OF
Obs MEAN STD DEV STD DEV PASSING

1 95 2.2 2.2 0.09180

2 100 2.2 2.2 0.55987
 ACCEPTANCE LIMITS FOR CONTENT UNIFORMITY
SAMPLING PLAN 2 ( 10 LOCATIONS, 4 PER LOCATION)
PROPORTION OF FUTURE SAMPLES PASSING THE USP TEST
WITH 95.0% ASSURANCE
FOR GIVEN SAMPLE MEAN, WITHIN AND BETWEEN LOCATION STD DEV

SAMPLE SAMPLE
SAMPLE WITHIN LOCATION BETWEEN LOCATION LOWER
MEAN STD DEV STD DEV BOUND

100 2.2 2.46 0.98750

Dissolution/Sampling Plan 1
If Dissolution/Sampling Plan 1 is selected, the following screen appears:

The user enters the value of Q, sample size (i.e., number of dosage units tested), the coverage
percentage (usually 90 or 95), and the confidence level (usually 90 or 95). There are three
choices for SAS output 1) The acceptance limit table, 2) an evaluation of the acceptance limit
table, and 3) a calculation of the lower bound based on sample results. The user can pick more
than one of these options. The second option calculates the probability of passing the
acceptance limit table based on the sample size, coverage, and confidence level selected. The
following table appears if this option is selected.
The user provides “true” values for the population mean and coefficient of variation (CV) - also
called relative standard deviation (RSD) and then using these “true” values, the program
calculates the probability that the sample results will fall within the acceptance limits. The entries
on this window must all be integers. The lower bound, upper bound, increment, and divisor are
entered for both the desired population means and CV’s. The default values indicate that an
evaluation is performed using population means of 95.0 and 100.0 and CV’s of 1.0 and 4.0 since
the mean goes from 950 to 1000 by 50 and dividing by 10 (i.e., 950/10, then 1000/10) and the CV
goes from 10 to 40 by 30 (i.e., 10/10, then 40/10).

If the 3rd option - Lower Bound for Sample Result - is selected, then the following screen
appears:
The user enters the sample mean and sample CV.

Sample output from each of these three options are given on the following pages.
 ACCEPTANCE LIMITS FOR DISSOLUTION (N = 6, Q = 80.0)
SAMPLING PLAN 1
(MEETING LIMITS GUARANTEES WITH 95.0 % ASSURANCE,
THAT AT LEAST 95.0% OF ALL FUTURE SAMPLES TESTED
FOR DISSOLUTION WILL PASS THE USP TEST)
TABLE ENTRY IS UPPER LIMIT ON CV OF 6 DISSOLUTION ASSAYS

MEAN CV MEAN CV MEAN CV MEAN CV MEAN CV

(% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%) (% CLAIM) (%)

80.2 0.09 84.2 1.80 88.2 3.34 92.2 4.28 96.2 4.69
80.4 0.18 84.4 1.88 88.4 3.41 92.4 4.31 96.4 4.70
80.6 0.27 84.6 1.96 88.6 3.47 92.6 4.33 96.6 4.72
80.8 0.36 84.8 2.04 88.8 3.54 92.8 4.36 96.8 4.73
81.0 0.44 85.0 2.12 89.0 3.60 93.0 4.38 97.0 4.75
81.2 0.53 85.2 2.20 89.2 3.66 93.2 4.41 97.2 4.77
81.4 0.62 85.4 2.28 89.4 3.71 93.4 4.43 97.4 4.78
81.6 0.71 85.6 2.36 89.6 3.77 93.6 4.45 97.6 4.80
81.8 0.79 85.8 2.44 89.8 3.82 93.8 4.47 97.8 4.81
82.0 0.88 86.0 2.52 90.0 3.87 94.0 4.49 98.0 4.82
82.2 0.96 86.2 2.59 90.2 3.92 94.2 4.51 98.2 4.84
82.4 1.05 86.4 2.67 90.4 3.96 94.4 4.53 98.4 4.85
82.6 1.13 86.6 2.75 90.6 4.00 94.6 4.55 98.6 4.87
82.8 1.22 86.8 2.82 90.8 4.04 94.8 4.57 98.8 4.88
83.0 1.30 87.0 2.90 91.0 4.08 95.0 4.59 99.0 4.90
83.2 1.39 87.2 2.98 91.2 4.12 95.2 4.60 99.2 4.91
83.4 1.47 87.4 3.05 91.4 4.15 95.4 4.62 99.4 4.92
83.6 1.55 87.6 3.12 91.6 4.19 95.6 4.64 99.6 4.94
83.8 1.63 87.8 3.20 91.8 4.22 95.8 4.65 99.8 4.95
84.0 1.72 88.0 3.27 92.0 4.25 96.0 4.67 100.0 4.97
ACCEPTANCE LIMITS FOR DISSOLUTION (N = 6, Q = 80.0)
SAMPLING PLAN 1
PROBABILITY OF PASSING ACCEPTANCE LIMIT TABLE
CONFIDENCE LEVEL = 95.0 AND LOWER BOUND = 95.0

PROBABILITY
OF
U CV PASSING

95 1 1.00000
100 1 1.00000
95 4 0.73988
100 4 0.81098
ACCEPTANCE LIMITS FOR DISSOLUTION (N = 6, Q = 80.0)
SAMPLING PLAN 1
PROPORTION OF FUTURE SAMPLES PASSING THE USP TEST
FOR A GIVEN SAMPLE MEAN AND CV WITH 95.0% ASSURANCE

SAMPLE SAMPLE
MEAN STD DEV LOWER
(% CLAIM) (% CLAIM) CV BOUND

100 4 4 0.99824
Dissolution/Sampling Plan 2

If Dissolution/Sampling Plan 2 is selected, the following screen appears:

The user enters Q, the number of locations, the number of dosage units per location, the
coverage probability, and the confidence level. There are three choices for SAS output 1) The
acceptance limit table, 2) an evaluation of the acceptance limit table, and 3) a calculation of the
lower bound based on sample results. The user can pick more than one of these options. The
second option calculates the probability of passing the acceptance limit table based on the
sample size, coverage, and confidence level selected. The following table appears if this option
is selected.
The user provides “true” values for the population mean, coefficient of variation (CV) within
locations, and CV for the between location. Using these “true” values, the program calculates the
probability that the sample results will fall within the acceptance limits. The entries on this
window must all be integers. The lower bound, upper bound, increment, and divisor are entered
for both the desired population means and within/between location CV’s. The default values
indicate that an evaluation is performed using population means of 95.0 and 100.0, within location
CV of 2.2, and between location CV’ of 2.2 since the mean goes from 950 to 1000 by 50 and
dividing by 10 (i.e., 950/10, then 1000/10) and the CV’s go from 22 to 22 by 10 (i.e., only one
value - 22/10).

If the 3rd option - Lower Bound for Sample Result - is selected, then the following screen
appears:
The user enters the sample mean, within sample standard deviation, and between sample
standard deviation [Note: This is just the sample standard deviation of the sample means, not a
variance component!]

Sample output from each of these three options are given on the following pages.
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25

SE

0.25 80.50 80.90 81.40 81.80 82.20 82.70 83.10 83.50 84.00 84.40 84.80 85.30 85.70 86.10 86.60 87.00 87.50

0.50 80.60 81.00 81.40 81.80 82.20 82.70 83.10 83.50 84.00 84.40 84.80 85.30 85.70 86.10 86.60 87.10 87.50

0.75 80.60 81.00 81.40 81.80 82.30 82.70 83.10 83.50 84.00 84.40 84.80 85.30 85.70 86.20 86.60 87.10 87.60

1.00 80.70 81.10 81.50 81.90 82.30 82.70 83.10 83.60 84.00 84.40 84.90 85.30 85.70 86.20 86.60 87.10 87.60

1.25 80.80 81.10 81.50 81.90 82.30 82.70 83.20 83.60 84.00 84.40 84.90 85.30 85.70 86.20 86.60 87.10 87.60

1.50 80.90 81.20 81.60 82.00 82.40 82.80 83.20 83.60 84.00 84.50 84.90 85.30 85.80 86.20 86.60 87.10 87.60

1.75 81.00 81.30 81.60 82.00 82.40 82.80 83.20 83.60 84.10 84.50 84.90 85.30 85.80 86.20 86.70 87.10 87.60

2.00 81.10 81.40 81.70 82.10 82.50 82.90 83.30 83.70 84.10 84.50 84.90 85.40 85.80 86.20 86.70 87.10 87.70

2.25 81.20 81.50 81.80 82.20 82.50 82.90 83.30 83.70 84.10 84.50 85.00 85.40 85.80 86.30 86.70 87.20 87.70

2.50 81.30 81.60 81.90 82.20 82.60 83.00 83.40 83.80 84.20 84.60 85.00 85.40 85.80 86.30 86.70 87.20 87.70

2.75 81.40 81.70 82.00 82.30 82.70 83.00 83.40 83.80 84.20 84.60 85.00 85.50 85.90 86.30 86.80 87.20 87.80

3.00 81.50 81.80 82.10 82.40 82.70 83.10 83.50 83.90 84.30 84.70 85.10 85.50 85.90 86.30 86.80 87.30 87.80

3.25 81.60 81.90 82.20 82.50 82.80 83.20 83.50 83.90 84.30 84.70 85.10 85.50 86.00 86.40 86.80 87.30 87.90

3.50 81.70 82.00 82.30 82.60 82.90 83.20 83.60 84.00 84.40 84.80 85.20 85.60 86.00 86.40 86.90 87.40 87.90
3.75 81.80 82.10 82.30 82.70 83.00 83.30 83.70 84.00 84.40 84.80 85.20 85.60 86.00 86.50 86.90 87.50 88.00

4.00 81.90 82.10 82.40 82.70 83.10 83.40 83.80 84.10 84.50 84.90 85.30 85.70 86.10 86.50 87.00 87.50 88.10

4.25 82.00 82.20 82.50 82.80 83.20 83.50 83.80 84.20 84.60 84.90 85.30 85.70 86.20 86.60 87.10 87.60 88.20
Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25

SE

4.50 82.00 82.30 82.60 82.90 83.20 83.60 83.90 84.30 84.60 85.00 85.40 85.80 86.20 86.70 87.20 87.70 88.30

4.75 82.10 82.40 82.70 83.00 83.30 83.70 84.00 84.30 84.70 85.10 85.50 85.90 86.30 86.70 87.20 87.80 88.40

5.00 82.20 82.50 82.80 83.10 83.40 83.70 84.10 84.40 84.80 85.10 85.50 85.90 86.40 86.80 87.30 87.90 88.60

5.25 82.30 82.60 82.90 83.20 83.50 83.80 84.20 84.50 84.90 85.20 85.60 86.00 86.40 86.90 87.40 88.00 88.70

5.50 82.40 82.70 83.00 83.30 83.60 83.90 84.20 84.60 84.90 85.30 85.70 86.10 86.60 87.00 87.60 88.20 88.90

5.75 82.50 82.80 83.10 83.40 83.70 84.00 84.30 84.70 85.00 85.40 85.80 86.20 86.70 87.20 87.70 88.40 89.10

6.00 82.60 82.90 83.20 83.50 83.80 84.10 84.40 84.80 85.10 85.50 85.90 86.30 86.80 87.30 87.90 88.60 89.30

6.25 82.70 83.00 83.30 83.60 83.90 84.20 84.60 84.90 85.30 85.60 86.00 86.50 87.00 87.50 88.10 88.80 89.60

6.50 82.90 83.10 83.40 83.70 84.00 84.40 84.70 85.00 85.40 85.80 86.20 86.60 87.10 87.70 88.30 89.00 89.90

6.75 83.00 83.30 83.60 83.90 84.20 84.50 84.80 85.20 85.50 85.90 86.40 86.80 87.30 87.90 88.60 89.30 90.20

7.00 83.10 83.40 83.70 84.00 84.30 84.70 85.00 85.30 85.70 86.10 86.60 87.00 87.60 88.20 88.90 89.70 90.60

7.25 83.30 83.60 83.90 84.20 84.50 84.80 85.20 85.50 85.90 86.30 86.80 87.30 87.90 88.50 89.20 90.00 91.00

7.50 83.50 83.80 84.10 84.40 84.70 85.10 85.40 85.80 86.20 86.60 87.10 87.60 88.20 88.80 89.60 90.40 91.40

7.75 83.80 84.10 84.40 84.70 85.00 85.30 85.70 86.10 86.50 86.90 87.40 87.90 88.60 89.30 90.00 90.90 91.80
8.00 84.10 84.40 84.70 85.00 85.30 85.60 86.00 86.40 86.80 87.30 87.80 88.40 89.00 89.70 90.50 91.40 92.30

8.25 84.40 84.70 85.00 85.30 85.70 86.00 86.40 86.80 87.20 87.70 88.20 88.80 89.50 90.20 91.00 91.90 92.80

8.50 84.80 85.10 85.40 85.80 86.10 86.40 86.80 87.20 87.70 88.20 88.70 89.30 90.00 90.70 91.50 92.40 93.40
Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25

SE

8.75 85.30 85.60 85.90 86.20 86.60 86.90 87.30 87.80 88.20 88.70 89.30 89.90 90.60 91.30 92.10 93.00 93.90

9.00 85.80 86.10 86.50 86.80 87.10 87.50 87.90 88.30 88.80 89.30 89.90 90.50 91.20 91.90 92.70 93.50 94.50

9.25 86.50 86.80 87.10 87.40 87.80 88.10 88.50 89.00 89.40 90.00 90.50 91.10 91.80 92.50 93.30 94.10 95.00

9.50 87.10 87.40 87.70 88.10 88.40 88.80 89.20 89.60 90.10 90.60 91.20 91.80 92.40 93.20 93.90 94.70 95.60

9.75 87.80 88.10 88.40 88.80 89.10 89.50 89.90 90.30 90.80 91.30 91.90 92.50 93.10 93.80 94.60 95.40 96.20

10.00 88.50 88.80 89.20 89.50 89.80 90.20 90.60 91.10 91.50 92.00 92.60 93.10 93.80 94.50 95.20 96.00 96.80

10.25 89.30 89.60 89.90 90.20 90.60 91.00 91.40 91.80 92.20 92.70 93.30 93.80 94.50 95.10 95.90 96.60 97.40

10.50 90.00 90.30 90.60 91.00 91.30 91.70 92.10 92.50 93.00 93.50 94.00 94.50 95.20 95.80 96.50 97.30 98.10

10.75 90.80 91.10 91.40 91.70 92.10 92.40 92.80 93.30 93.70 94.20 94.70 95.30 95.90 96.50 97.20 97.90 98.70

11.00 91.50 91.80 92.10 92.50 92.80 93.20 93.60 94.00 94.40 94.90 95.40 96.00 96.60 97.20 97.90 98.60 99.40

11.25 92.30 92.60 92.90 93.20 93.60 94.00 94.30 94.80 95.20 95.70 96.20 96.70 97.30 97.90 98.60 99.30 100.00

11.50 93.10 93.40 93.70 94.00 94.30 94.70 95.10 95.50 95.90 96.40 96.90 97.40 98.00 98.60 99.30 100.00

11.75 93.80 94.10 94.40 94.80 95.10 95.50 95.90 96.30 96.70 97.20 97.60 98.20 98.70 99.30 100.00

12.00 94.60 94.90 95.20 95.50 95.90 96.30 96.60 97.00 97.50 97.90 98.40 98.90 99.50
12.25 95.40 95.70 96.00 96.30 96.70 97.00 97.40 97.80 98.20 98.70 99.20 99.70

12.50 96.20 96.50 96.80 97.10 97.40 97.80 98.20 98.60 99.00 99.40 99.90

12.75 96.90 97.20 97.60 97.90 98.20 98.60 99.00 99.40 99.80
Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50 3.75 4.00 4.25

SE

13.00 97.70 98.00 98.30 98.70 99.00 99.40 99.70

13.25 98.50 98.80 99.10 99.50 99.80

13.50 99.30 99.60 99.90

Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

4.50 4.75 5.00 5.25 5.50 5.75 6.00 6.25 6.50 6.75 7.00 7.25

SE

0.25 88.10 88.70 89.50 90.30 91.40 92.60 94.00 95.40 96.90 98.40 99.90

0.50 88.10 88.70 89.50 90.40 91.40 92.60 94.00 95.40 96.90 98.40 99.90

0.75 88.10 88.70 89.50 90.40 91.40 92.70 94.00 95.50 96.90 98.40 99.90

1.00 88.10 88.80 89.50 90.40 91.50 92.70 94.10 95.50 97.00 98.50 100.00

1.25 88.10 88.80 89.50 90.40 91.50 92.80 94.10 95.60 97.00 98.50 100.00

1.50 88.20 88.80 89.60 90.50 91.60 92.80 94.20 95.60 97.10 98.60

1.75 88.20 88.90 89.60 90.50 91.60 92.90 94.30 95.70 97.20 98.60

2.00 88.20 88.90 89.70 90.60 91.70 93.00 94.40 95.80 97.20 98.70

2.25 88.30 88.90 89.70 90.70 91.80 93.10 94.50 95.90 97.30 98.80

2.50 88.30 89.00 89.80 90.80 91.90 93.20 94.60 96.00 97.50 98.90

2.75 88.40 89.10 89.90 90.90 92.00 93.30 94.70 96.10 97.60 99.10

3.00 88.40 89.10 90.00 91.00 92.20 93.50 94.80 96.30 97.70 99.20

3.25 88.50 89.20 90.10 91.10 92.30 93.60 95.00 96.40 97.90 99.30

3.50 88.60 89.30 90.20 91.30 92.50 93.80 95.20 96.60 98.00 99.50
 3.75 88.70 89.40 90.30 91.40 92.60 93.90 95.30 96.70 98.20 99.60

4.00 88.80 89.60 90.50 91.60 92.80 94.10 95.50 96.90 98.40 99.80

4.25 88.90 89.70 90.70 91.80 93.00 94.30 95.70 97.10 98.60 100.00
Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

4.50 4.75 5.00 5.25 5.50 5.75 6.00 6.25 6.50 6.75 7.00 7.25

SE

4.50 89.00 89.90 90.80 92.00 93.20 94.60 95.90 97.30 98.80

4.75 89.20 90.00 91.00 92.20 93.50 94.80 96.20 97.60 99.00

5.00 89.30 90.20 91.30 92.40 93.70 95.00 96.40 97.80 99.20

5.25 89.50 90.40 91.50 92.70 94.00 95.30 96.70 98.00 99.50

5.50 89.70 90.70 91.80 93.00 94.30 95.60 96.90 98.30 99.70

5.75 90.00 90.90 92.10 93.30 94.50 95.90 97.20 98.60 100.00

6.00 90.20 91.20 92.40 93.60 94.90 96.20 97.50 98.90

6.25 90.50 91.60 92.70 93.90 95.20 96.50 97.80 99.20

6.50 90.80 91.90 93.00 94.30 95.50 96.80 98.10 99.50

6.75 91.20 92.30 93.40 94.60 95.90 97.20 98.50 99.80

7.00 91.60 92.60 93.80 95.00 96.20 97.50 98.80

7.25 92.00 93.10 94.20 95.40 96.60 97.90 99.20

7.50 92.40 93.50 94.60 95.80 97.00 98.30 99.50

7.75 92.90 93.90 95.10 96.20 97.40 98.70 99.90

 8.00 93.30 94.40 95.50 96.70 97.80 99.10

8.25 93.80 94.90 96.00 97.10 98.30 99.50

8.50 94.30 95.40 96.50 97.60 98.70 99.90

Œ

(Continued)
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
LOWER BOUND = 95.0, CONFIDENCE LEVEL = 95.0
TABLE ENTRIES ARE LOWER LIMITS ON THE MEAN
OF 60 ASSAYS- 6 ASSAYS AT EACH OF 10 DIFFERENT LOCATIONS
SE IS THE POOLED WITHIN LOCATION STANDARD DEVIATION
STANDARD DEVIATIONS AND MEANS ARE EXPRESSED IN % CLAIM

STANDARD DEVIATION OF LOCATION MEANS

4.50 4.75 5.00 5.25 5.50 5.75 6.00 6.25 6.50 6.75 7.00 7.25

SE

8.75 94.90 95.90 96.90 98.10 99.20

9.00 95.40 96.40 97.50 98.50 99.70

9.25 96.00 96.90 98.00 99.00

9.50 96.50 97.50 98.50 99.60

9.75 97.10 98.10 99.10

10.00 97.70 98.60 99.60

10.25 98.30 99.20

10.50 98.90 99.80

10.75 99.60

11.00

11.25

11.50

11.75

12.00
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2 ( 10 LOCATIONS, 6 PER LOCATION)
PROPORTION OF FUTURE SAMPLES PASSING THE USP TEST
WITH 95.0% ASSURANCE
GIVEN THE SAMPLE MEAN, WITHIN AND BETWEEN STD DEV

SAMPLE SAMPLE
SAMPLE WITHIN LOCATION BETWEEN LOCATION LOWER
MEAN STD DEV STD DEV BOUND

100 2.2 2.46 1

 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
PROBABILITY OF PASSING DISSOLUTION ACCEPTANCE LIMIT TABLE
WITH 6 ASSAYS AT EACH OF 10 LOCATIONS
CONFIDENCE LEVEL = 95.0 & LOWER BOUND = 95.0

PROBABILITY
WITHIN LOCATION BETWEEN LOCATION OF
Obs MEAN STD DEV STD DEV PASSING

1 95 2.2 2.2 1.00000

2 100 2.2 2.2 1.00000
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2
PROBABILITY OF PASSING DISSOLUTION ACCEPTANCE LIMIT TABLE
WITH 6 ASSAYS AT EACH OF 10 LOCATIONS
CONFIDENCE LEVEL = 95.0 & LOWER BOUND = 95.0

PROBABILITY
WITHIN LOCATION BETWEEN LOCATION OF
Obs MEAN STD DEV STD DEV PASSING

1 95 2.2 2.2 1.00000

2 100 2.2 2.2 1.00000
 ACCEPTANCE LIMITS FOR DISSOLUTION (Q = 80.0)
SAMPLING PLAN 2 ( 10 LOCATIONS, 6 PER LOCATION)
PROPORTION OF FUTURE SAMPLES PASSING THE USP TEST
WITH 95.0% ASSURANCE
GIVEN THE SAMPLE MEAN, WITHIN AND BETWEEN STD DEV

SAMPLE SAMPLE
SAMPLE WITHIN LOCATION BETWEEN LOCATION LOWER
MEAN STD DEV STD DEV BOUND

100 2.2 2.46 1

 Appendix
USP Content Uniformity and Dissolution Tests

Content Uniformity

Stage 1) Test 10 dosage units

Requirements are met if the acceptance value (defined below) of the first 10
dosage units is ≤ 15.

Otherwise go to stage 2.

Stage 2)

Test an additional 20 units.

Pass if for all 30 units the following criteria are met:

The acceptance value of the 30 dosage units is ≤ 15

No dosage unit deviates from the calculated value of M (defined below)

by more than 25% of M

The acceptance value (AV) is defined as |M -⎯X| + ks

Where k = 2.4 for stage 1; k = 2.0 for stage 2

⎯X is the sample mean

s is the standard deviation of the observations.

M is based on T which is the Target content per dosage unit at the time of manufacture,
expressed as a percentage of the label claim. Unless otherwise specified in the individual
monograph, T is the average of the limits specified in the potency definition in the individual
monograph.

M is defined as follows:

When T ≤ 101.5

Then M = max{ 98.5, ⎯X} if ⎯X ≤ 100

M = min{101.5, ⎯X} if ⎯X > 100

When T > 101.5

Then M = max{ 98.5, ⎯X} if ⎯X ≤ 100

M = min{T, ⎯X} if ⎯X > 100
Dissolution:

Stage 1) Test 6 units (Result = % released at specified dissolution time point)

Pass if all 6 results ≥ Q + 5

Otherwise go to stage 2.

Stage 2) Test 6 additional units

Pass if for all 12 units the following criteria are met:

1) Mean result ≥ Q

2) No result ≤ Q - 15

Otherwise go to stage 3.

Stage 3) Test 12 additional units

Pass if for all 24 units the following criteria are met:

1) Mean result ≥ Q

2) No more than two results ≤ Q – 15 with no results ≤ Q - 25

Otherwise Fail.