Evaluation of Validation
Content Uniformity Test
Results Using Lower
Probability Bound
Distribution Charts
Pramote Cholayudth
[
For more Author
information,
go to
ivthome.com/bios
ABOUT THE AUTHOR
Pramote Cholayudth is a validation consultant to Biolab in Thailand and executive director of Valitech, a well-
established GMP and validation service firm to the pharmaceutical industry. He is a guest speaker on process validation
to the industry organized by local FDA. He can be contacted by e-mail at cpramote2000@yahoo.com.
USP Criteria Stage 1: Assay 10 units. USP Criteria Stage 2: Assay 20 additional units.
Pass if the following criteria are met. Pass if, for all 30 units, the following criteria are met.
1) Relative standard deviation (RSD) is not more 1) Relative standard deviation (RSD) is not more than 7.8%
than 6.0% (n = 10) (n = 30)
2) Not more than c unit(s) is outside 85 – 115% label 2) Not more than c unit(s) is outside 85 – 115% label claim
claim (LC) and no unit is outside 75 – 125% LC (LC) and no unit is outside 75 – 125% LC where c = 1 for
where c = 0 for tablet and 1 for capsule tablet and 3 for capsule
1. 1.
2. Xmin > 0.75M and
Xmax < 1.25M
Where M = reference value, s = standard deviation,
5 content uniformity data mean, Xmin 5 minimum and
Xmax 5 maximum (individual values)
To help understand the new USP test acceptance cri- Table IV. The formulae in Tables IV, XIV, and XV may
teria, a scenario for calculation of acceptance value be copied to construct the Microsoft Excel file for com-
(AV) is introduced: In a new USP content uniformity puting the probability. However, note that the sample
testing, the stage 1 test results (n = 10) are mean = 101.2 is taken in accordance with sampling plan 1 (one unit
% of label claim (LC) and standard deviation (SD) = from each of 30 locations).
4.15 % LC. The manufacturing target is 102.5 % LC.
The acceptance value is (101.2-101.2) + 2.4x4.15 = 9.96
(< 15), so the AV limit is met. PROBABILITY OF PASSING THE NEW
CONTENT UNIFORMITY TEST
The article “Using Bergum’s New Method and MS Excel
PROBABILITY OF PASSING THE CURRENT to Determine the Probability of Passing the New ICH
CONTENT UNIFORMITY TEST USP 29 Content Uniformity Test” (8), has the formu-
According to Bergum’s method described in “Use of lae as illustrated in Table V. The readers may copy the
the Bergum Method and MS Excel to Determine the formulae in Tables V, VI, and VII to construct the Mi-
Probability of Passing the USP Content Uniformity crosoft Excel file. Also note that the sample is taken in
Test” (7), the probability formulae are illustrated in accordance with sampling plan 1.
The cells C17 – C21 are entered with sample data information. The numerical results in the other cells, including the probability and
LB results in C7, C14, and C15, are generated by the program.
When sample data (n = 30) associated with sample JUSTIFICATION OF USING THE
mean: 98% LC and sample RSD: 3.6% are plotted, the PROBABILITY CHARTS
lower probability bound distributions can be con- Validation content uniformity test results must be eval-
structed and illustrated in Figures 1 and 2. In these fig- uated for probability of passing the test. The evalua-
ures, one can imagine how a sample data comprising tion employs Bergum’s methods by using statistical
a mean and relative standard deviation (RSD) values programs like SAS or Microsoft Excel. To provide a
will influence the probability of passing a content uni- practical tool as an alternative to such complicated
formity test. Furthermore, the way in which a larger methods, the distribution curves for lower probability
sample size influences the distribution patterns is bounds constructed in a high precision scale are intro-
demonstrated in Figure 3. duced so that validation practitioners can use them to
determine the probability instead of using the pro-
grams. However one must realize that the use of Excel
for validation work requires validation of the spread-
sheet itself (e.g., Tables IV, V, VI, and VII).
Figure 2: Distribution Curves for Probability of Passing USP Content Uniformity Test (n=30).
Figure 3: Distribution Curves for Probability of Passing USP Content Uniformity Test (n = 70).
tablet product tested using the current USP content To justify the use of probability charts is to justify
uniformity test with sample mean = 100.15% LC and such deviations, so analysis of the deviation data in
RSD = 3.9%, is performed by determining on Figure Tables VIII, IX, and X is carried out. Each numerical
4 the intersection of the curves for mean = 100.2 value of mean and RSD is intended to provide the sec-
(rounded up) and RSD = 3.9. The point will indicate ond decimal digits with 4, 5, or 6 (e.g., 97.04, 4.25,
the lower probability bound of approximately 97%. 97.06) so that when the numbers are rounded up, the
The probability generated using the Excel program is maximized deviation in the probability determination
97.46%. The determined value deviates slightly from result is challenged. The results are satisfactory since
the computed one. most of the deviations are close to or equal to the cal-
culated results except for those data sets with means
greater than the target (> 100% LC) and RSDs with the
second decimals with 4, 5, or 6 where the maximum
biases (deviation) will occur. In the worst case, the
maximum deviation is 5.3% (Table IX) or 4.6% (Table
X). Therefore, the use of these types of probability charts
should be justified.
Sampling Plan 2 (More than One Unit, e.g., 7 Units, from Each Location)
* Modified from Reference (9), n: sample size at each location, L: number of locations
A B C D E F G H I J K
1 Stratified Sampling Location # (Sampling Plan 2: 3 Units x 10 Locations)
Unit #
2 1 2 3 4 5 6 7 8 9 10
3 1 95.01 93.91 99.37 97.97 94.93 93.83 101.31 98.74 97.87 106.44
4 2 100.93 99.11 103.93 105.8 98.52 105.85 96.48 97.53 103.71 99.18
5 3 102.27 98.96 99.83 97.64 100.27 98.68 97.46 95.83 98.23 96.14
6 SQD 29.85 17.52 12.61 42.67 14.82 73.14 13.04 4.27 21.42 56.01
20 *These data are used for determination of the probability in Figure 5 where rounded numbers are used
21 i.e., 99.19 ➔ 99.2 (C7), 3.78 ➔ 3.8 (F13) & 2.36 ➔ 2.4 (F14).
22 **Calculated (in Tables IV & V ) from the upper & lower bounds estimated using ANOVA (11)
SE = Square Root of Mean Square Error, SM = Standard Deviation of Location Means, * Maximum
are that a lot of charts will have to be generated, since 9. Pluta, P., “Keep in Step with Confidence; Keep in Step
one chart may be broken down into two or three charts, through Benchmarking” Journal of Validation Technology,
resulting in complication of their use. Justification of Volume 12, No. 1, November 2005.
the accuracy (i.e., deviation) on practical basis, as de- 10. Cholayudth, P., “Application of Probability of Passing
scribed earlier, should be acceptable. Since the worst Multiple Stage Tests in Benchmarking and Validation of
case probability results (low results at 50 to 60% with Processes” Journal of Validation Technology, Volume 13,
deviation of up to 5 or 6%) will occur only to inade- No. 4, August 2007.
quately controlled and/or developed processes. The 11. Chow, S.C. and Liu, Statistical Design and Analysis in Phar-
adequately developed processes with proper in-process maceutical Science: Validation, Process Controls, Practical
control will not fall into this case (i.e., the deviation and Clinical Applications, 3rd ed. New York: Marcel Dekker,
will be much less than 5%). Inc. JVT
D4 =MAX((FDIST(10/((0.06^2)*(1+10*(B5/B7)^2)),(1+10*(B5/B7)^2)^2/(1+2*10*(B5/B7)^2),10-1))+
((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^10)-
1,(FDIST(30/((0.078^2)*(1+30*(B5/B7)^2)),(1+30*(B5/B7)^2)^2/(1+2*30*(B5/B7)^2),30-1))+((NORMSDIST((115-B5)/B7)-
NORMSDIST((85-B5)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^29)*(((NORMS-
DIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^1))-1,0)
D5 =MAX((FDIST(10/((0.06^2)*(1+10*(B6/B7)^2)),(1+10*(B6/B7)^2)^2/(1+2*10*(B6/B7)^2),10-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^10)-
1,(FDIST(30/((0.078^2)*(1+30*(B6/B7)^2)),(1+30*(B6/B7)^2)^2/(1+2*30*(B6/B7)^2),30-1))+((NORMSDIST((115-B6)/B7)-
NORMSDIST((85-B6)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^29)*(((NORMSDI
ST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^1))-1,0)
F7 =(FDIST(10/((0.06^2)*(1+10*(B5/B7)^2)),(1+10*(B5/B7)^2)^2/(1+2*10*(B5/B7)^2),10-1))+((NORMSDIST((115-
B5)/B7)-NORMSDIST((85-B5)/B7))^10+COMBIN(10,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-
B5)/B7))^9)*(((NORMSDIST((B5-75)/B7)-NORMSDIST((B5-85)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-
B5)/B7)))^1))-1
F8 =(FDIST(30/((0.078^2)*(1+30*(B5/B7)^2)),(1+30*(B5/B7)^2)^2/(1+2*30*(B5/B7)^2),30-1))+((NORMSDIST((115-
B5)/B7)-NORMSDIST((85-B5)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-
B5)/B7))^29)*(((NORMSDIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-
B5)/B7)))^1)+COMBIN(30,2)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^28)*(((NORMSDIST((85-B5)/B7)-N
ORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^2)+COMBIN(30,3)*((NORMS-
DIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^27)*(((NORMSDIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMS-
DIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^3))-1
F10 =(FDIST(10/((0.06^2)*(1+10*(B6/B7)^2)),(1+10*(B6/B7)^2)^2/(1+2*10*(B6/B7)^2),10-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^10+COMBIN(10,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-
B6)/B7))^9)*(((NORMSDIST((B6-75)/B7)-NORMSDIST((B6-85)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-
B6)/B7)))^1))-1
F11 =(FDIST(30/((0.078^2)*(1+30*(B6/B7)^2)),(1+30*(B6/B7)^2)^2/(1+2*30*(B6/B7)^2),30-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-
B6)/B7))^29)*(((NORMSDIST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-
B6)/B7)))^1)+COMBIN(30,2)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^28)*(((NORMSDIST((85-B6)/B7)-N
ORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^2)+COMBIN(30,3)*((NORMS-
DIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^27)*(((NORMSDIST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMS-
DIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^3))-1
ARTICLE:
Evaluation of Validation Content Uniformity Test Results
Using Probability Distribution Charts
By: Pramote Cholayudth
Probability charts provided in the following pages are presented in order of product
types, sampling plan types and overall sample sizes. All the charts are constructed on
95% joint confidence level. The charts for 1 unit x 60 locations are also available
although it is not practical to do the sampling. The author only wants the readers to
have the integrated views on this sampling plan 1. In the new USP test, the
probability charts provided are applicable to the processes with target of not more
than 101.5% label claim (LC). For processes with target > 101.5% LC, please
contact cpramote2000@yahoo.com.
Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x30 = 30, RSD = 2.1-4.7%)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x30 = 30, RSD = 2.2-4.8%)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x30 = 30, RSD = 2.5-5.1%)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x30 = 30, RSD = 2.6-5.2%)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 1x30 = 30, RSD = 2.0-4.6%)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 1x30 = 30, RSD = 2.1-4.7%)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x60 = 60, RSD = 2.7-5.3%)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x60 = 60, RSD = 2.8-5.4%)
100%
95%
2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)
3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x60 = 60, RSD = 3.0-5.6%)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x60 = 60, RSD = 3.1-5.7%)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 1x60 = 60, RSD = 2.7-5.3%)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 1x60 = 60, RSD = 2.8-5.4%)
100%
95%
2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)
3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 0.5)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 0.5)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 0.5)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 0.5)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 0.5)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 0.5)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.0)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.0)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 1.0)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 1.0)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.0)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.0)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.5)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.5)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 1.5)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 1.5)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.5)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.5)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.0)
100%
95%
1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)
2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 2.0)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.0)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 2.0)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.0)
100%
95%
1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)
2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.0)
100%
95%
1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)
2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.5)
100%
95%
1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)
2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.5)
100%
95%
1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)
2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.5)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 2.5)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 2.5)
100%
95%
1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)
2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.5)
100%
95%
1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)
2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 2.8)
100%
95%
1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)
2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.8)
100%
95%
1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)
2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 2.8)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.8)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 2.8)
100%
95%
1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)
2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 2.8)
100%
95%
1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)
2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 3.1)
100%
95%
1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)
2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 3.1)
100%
95%
1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)
2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 3.1)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 3.1)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 3.1)
100%
95%
1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)
2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 3.1)
100%
95%
1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)
2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 3.4)
100%
95%
1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)
2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 3.4)
100%
95%
1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)
2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 3.4)
100%
95%
2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)
3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 3.4)
100%
95%
2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)
3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.0-3.6, SM = 3.4)
100%
95%
1%
90%
1.2%
1.4%
85%
1.6%
1.8%
80%
Probability (%)
2%
2.2%
75% 2.4%
2.6%
70% 2.8%
3%
65% 3.2%
3.4%
60% 3.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.1-3.7, SM = 3.4)
100%
95%
1.1%
90%
1.3%
1.5%
85%
1.7%
1.9%
80%
Probability (%)
2.1%
2.3%
75% 2.5%
2.7%
70% 2.9%
3.1%
65% 3.3%
3.5%
60% 3.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.0-3.6, SM = 3.7)
100%
95%
1%
90%
1.2%
1.4%
85%
1.6%
1.8%
80%
Probability (%)
2%
2.2%
75% 2.4%
2.6%
70% 2.8%
3%
65% 3.2%
3.4%
60% 3.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.1-3.7, SM = 3.7)
100%
95%
1.1%
90%
1.3%
1.5%
85%
1.7%
1.9%
80%
Probability (%)
2.1%
2.3%
75% 2.5%
2.7%
70% 2.9%
3.1%
65% 3.3%
3.5%
60% 3.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 3.7)
100%
95%
1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)
2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 3.7)
100%
95%
2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)
3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 0.7-3.3, SM = 3.7)
100%
95%
0.7%
90%
0.9%
1.1%
85%
1.3%
1.5%
80%
Probability (%)
1.7%
1.9%
75% 2.1%
2.3%
70% 2.5%
2.7%
65% 2.9%
3.1%
60% 3.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 0.8-3.4, SM = 3.7)
100%
95%
0.8%
90%
1%
1.2%
85%
1.4%
1.6%
80%
Probability (%)
1.8%
2%
75% 2.2%
2.4%
70% 2.6%
2.8%
65% 3%
3.2%
60% 3.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 0.5)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 0.5)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 0.5)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.2-5.8, SM = 0.5)
100%
95%
3.2%
90%
3.4%
3.6%
85%
3.8%
4%
80%
Probability (%)
4.2%
4.4%
75% 4.6%
4.8%
70% 5%
5.2%
65% 5.4%
5.6%
60% 5.8%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 0.5)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.8-5.4, SM = 0.5)
100%
95%
2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)
3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.0)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.0)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 1.0)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 1.0)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.0)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.8-5.4, SM = 1.0)
100%
95%
2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)
3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 1.5)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.5)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 1.5)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 1.5)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.5)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.5)
100%
95%
2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)
3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.0)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.0)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.0)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.0)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.0)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.0)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.5)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.5)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.5)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.5)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.5)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.5)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.8)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.8)
100%
95%
2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)
3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.8)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.8)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 2.8)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.8)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.1)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.1)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.1)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 3.1)
100%
95%
3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)
4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.1)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.1)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.4)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.4)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 2.9-5.5, SM = 3.4)
100%
95%
2.9%
90%
3.1%
3.3%
85%
3.5%
3.7%
80%
Probability (%)
3.9%
4.1%
75% 4.3%
4.5%
70% 4.7%
4.9%
65% 5.1%
5.3%
60% 5.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.4)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.3-4.9, SM = 3.4)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.4)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.7)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.7)
100%
95%
2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)
3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 2.9-5.5, SM = 3.7)
100%
95%
2.9%
90%
3.1%
3.3%
85%
3.5%
3.7%
80%
Probability (%)
3.9%
4.1%
75% 4.3%
4.5%
70% 4.7%
4.9%
65% 5.1%
5.3%
60% 5.5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.7)
100%
95%
3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)
4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.3-4.9, SM = 3.7)
100%
95%
2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)
3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)
Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.7)
100%
95%
2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)
3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%
55%
50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0