Stage 1 Diffusion Master Worksheet

Disclaimer and Instructions

The spreadsheet is provided unvalidated, and is for information

purposes only. Calculations should be verified before GMP/GLP use.

This spreadsheet is for the calculation of results for 5 sample point

diffusion cell tests.

The worksheets of the spreadsheet are protected to prevent

accidental changes to the formulas. They can be unprotected without
a password for corrections or adjustments

Green cells with black text are for data entry; enter the appropriate
data into these cells

File Name: 476218661.xls

 File Name: 476218661.xls

Diffusion Cell Calculation Program for Six

Cells with Five Sample Time Points
Company Spectre Pharma
Analyst Suhas

Active Ingredient Imatinib

Label Claim 5%
Product Name Imatinib Gel
Manufacturer Spectre Pharma
Lot 1
Expiration Date Sunday, December 01, 2019

Test 1
Run Date Saturday, May 04, 2019
File Name 1

Reference 1
Run Date Saturday, May 04, 2019
File Name 1

Notes/Comments
For comparison

Analyst Signature:_______________________________________________ Date:_________________________

Reference 1 File Name: 476218661.xls

Standards Cell Orifice Dia. (cm) 1.5 Orifice Area 1.767

Injection Area otal Volume Removed 0.200 andard Conc. (mg/mL) 0.50000
1 1000
2 Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
3 S/N
4 Cell Volume 7.000 7.000 7.000 7.000 7.000 7.000
5 Time (min) Peak Area
6 60 50 55 57 58 61 48
7 120 75 73 76 80 77 79
8 180 100 103 105 97 98 99
Average 1000 240 151 153 152 150 155 155
RSD #DIV/0! 300 200 199 201 203 201 200
Acceptable #DIV/0!
Concentration
Time (min) Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
60 99.0 108.9 112.9 114.9 120.8 95.1
120 148.5 144.6 150.5 158.4 152.5 156.5
180 198.1 204.0 208.0 192.1 194.1 196.1
240 299.1 303.0 301.1 297.1 307.0 307.0
300 396.1 394.1 398.1 402.1 398.1 396.1

Time Total Amount Released (micrograms/sq.cm)

Sqrt T1 7.746 60 99.0 108.9 112.9 114.9 120.8 95.1
Sqrt T2 10.954 120 151.4 147.7 153.8 161.7 156.0 159.2
Sqrt T3 13.416 180 205.1 211.2 215.5 199.9 201.9 203.3
Sqrt T4 15.492 240 311.8 316.1 314.5 310.4 320.3 319.8
Sqrt T5 17.321 300 417.4 415.9 420.2 423.8 420.2 417.7
Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
Slopes 32.6 31.9 31.6 31.2 31.0 33.0
R-Squared 0.922 0.916 0.916 0.888 0.886 0.929

Average %RSD Amount Released micrograms/sq.cm

Slope 31.9 2.5 Time Avg. Release %RSD
R-Squared 0.909 2.0 60 108.6 9.0
120 154.9 3.3
180 206.2 2.9
240 315.5 1.3
300 419.2 0.7

Total Amount Released

450.0

400.0
micrograms/sq.cm

350.0

300.0

Cell 1
250.0
Cell 2

Cell 3

200.0 Cell 4

Cell 5

150.0 Cell 6

100.0

50.0

0.0
6.000 8.000 10.000 12.000 14.000 16.000 18.000
Square Root of TIme

Analyst Signature:_______________________________________________ Date:_________________________

 Test 1 File Name: 476218661.xls

Standards Cell Orifice Dia. (cm) 1.5 Orifice Area 1.767

Injection Area Total Volume Removed 0.200 andard Conc. (mg/mL) 0.50000
1 1000
2 Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
3 S/N
4 Cell Volume 7.000 7.000 7.000 7.000 7.000 7.000
5 Time (min) Peak Area
6 60 60 55 61 63 61 58
7 120 75 81 85 80 82 79
8 180 100 110 111 103 111 100
Average 1000 240 151 155 160 165 157 152
RSD #DIV/0! 300 200 210 202 205 211 220
Acceptable #DIV/0!
Concentration
Time (min) Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
60 118.8 108.9 120.8 124.8 120.8 114.9
120 148.5 160.4 168.4 158.4 162.4 156.5
180 198.1 217.9 219.8 204.0 219.8 198.1
240 299.1 307.0 316.9 326.8 311.0 301.1
300 396.1 415.9 400.1 406.0 417.9 435.7

Time Total Amount Released (micrograms/sq.cm)

Sqrt T1 7.746 60 118.8 108.9 120.8 124.8 120.8 114.9
Sqrt T2 10.954 120 151.9 163.5 171.8 162.0 165.9 159.7
Sqrt T3 13.416 180 205.7 225.6 228.1 212.1 227.9 205.8
Sqrt T4 15.492 240 312.4 320.9 331.4 340.7 325.3 314.5
Sqrt T5 17.321 300 418.0 438.6 423.7 429.3 441.2 457.7
Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6
Slopes 30.8 33.4 31.4 32.1 32.6 34.0
R-Squared 0.892 0.926 0.933 0.897 0.914 0.870

Average %RSD Amount Released micrograms/sq.cm

Slope 32.4 3.8 Time Avg. Release %RSD
R-Squared 0.906 2.6 60 118.2 4.7
120 162.5 4.1
180 217.5 5.0
240 324.2 3.3
300 434.7 3.3

500.0 Total Amount Released

450.0
micrograms/sq.cm

400.0

350.0

300.0
Cell 1

Cell 2
250.0 Cell 3

Cell 4

200.0 Cell 5

Cell 6

150.0

100.0

50.0

0.0
6.000 8.000 10.000 12.000 14.000 16.000 18.000
Square Root of Time

Analyst Signature:_______________________________________________ Date:_________________________

Results Report File Name: 476218661.xls

Test 1 Reference 1
Cell 1 2 3 4 5 6 Average RSD
Cell Slope 32.6 31.9 31.6 31.2 31.0 33.0 31.892 2.522
1 30.8 0.946 0.965 0.974 0.989 0.995 0.933
2 33.4 1.025 1.047 1.056 1.073 1.078 1.012
3 31.4 0.963 0.983 0.992 1.007 1.012 0.950
4 32.1 0.984 1.004 1.014 1.030 1.035 0.971
5 32.6 1.002 1.022 1.032 1.048 1.054 0.988
6 34.0 1.044 1.066 1.076 1.092 1.098 1.030
Average 32.395
RSD 3.762
0.933 0.946 0.950 0.963 0.965 0.971
0.974 0.983 0.984 0.988 0.989 0.992
0.995 1.002 1.004 1.007 1.012 1.012
1.014 1.022 1.025 1.030 1.030 1.032
1.035 1.044 1.047 1.048 1.054 1.056
1.066 1.073 1.076 1.078 1.092 1.098

The eighth T/R ratio converted to % is 98.2536062978288%

The 29th T/R ratio converted to % is 105.355284549466%

Which lie between 75% and 133.3% and is therefore equivalent to the Reference.
Average Amount Released (micrograms/sq.cm)
Time 60 120 180 240 300
Square Root 7.746 10.954 13.416 15.492 17.321
Test 1 118.2 162.5 217.5 324.2 434.7
Reference 1 108.6 154.9 206.2 315.5 419.2
micrograms/sq.cm

Average Amount Released

500.0
450.0
400.0
350.0
300.0
250.0
200.0 Test 1 Reference 1

150.0
100.0
50.0
0.0
6.000 8.000 10.000 12.000 14.000 16.000 18.000
Square root of time

Analyst Signature:_______________________________________________ Date:_________________________

Report File Name: 476218661.xls

Diffusion Cell Test Report

Test Information
Company Spectre Pharma Test 1
Analyst Suhas Run Date Saturday, May 04, 2019
Active Ingredient Imatinib File Name 1
Label Claim 0.05
Product Name Imatinib Gel Reference 1
Manufacturer Spectre Pharma Run Date Saturday, May 04, 2019
Lot 1 File Name 1
Expiration Date ###

Test Results (microgram / sq.cm)

Time Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6 Average %RSD
60 118.8 108.9 120.8 124.8 120.8 114.9 118.2 4.7
120 151.9 163.5 171.8 162.0 165.9 159.7 162.5 4.1
180 205.7 225.6 228.1 212.1 227.9 205.8 217.5 5.0
240 312.4 320.9 331.4 340.7 325.3 314.5 324.2 3.3
300 418.0 438.6 423.7 429.3 441.2 457.7 434.7 3.3

Reference Test (microgram / sq.cm)

Time Cell 1 Cell 2 Cell 3 Cell 4 Cell 5 Cell 6 Average %RSD
60 99.0 108.9 112.9 114.9 120.8 95.1 108.6 9.0
120 151.4 147.7 153.8 161.7 156.0 159.2 154.9 3.3
180 205.1 211.2 215.5 199.9 201.9 203.3 206.2 2.9
240 311.8 316.1 314.5 310.4 320.3 319.8 315.5 1.3
300 417.4 415.9 420.2 423.8 420.2 417.7 419.2 0.7

Slopes
Cell 1 2 3 4 5 6 Average %RSD
Test 1 30.8 33.4 31.4 32.1 32.6 34.0 32.4 3.8
Reference 1 32.6 31.9 31.6 31.2 31.0 33.0 31.9 2.5

Slope - T/R Ratios

0.933 0.946 0.950 0.963 0.965 0.971
0.974 0.983 0.984 0.988 0.989 0.992
0.995 1.002 1.004 1.007 1.012 1.012
1.014 1.022 1.025 1.030 1.030 1.032
1.035 1.044 1.047 1.048 1.054 1.056
1.066 1.073 1.076 1.078 1.092 1.098

The eighth T/R ratio converted to % is 98.2536062978288%

The 29th T/R ratio converted to % is 105.355284549466%
Which lie between 75% and 133.3% and is therefore equivalent to the Reference.

Notes/Comments
For comparison

Analyst Signature:_______________________________________________ Date:_________________________