Adapalene and BPO Gel 0.1% and 2.5% (RLD Vs TEST)

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Name: Determination of Adapalene from IVRT by HPLC

Test: IVRT
Standard Details
Details of Instrumemnt Name Adapalene
Date: 4/28/2023 In-house Lot # S/0128/23
LNB Ref #: AD0206, Page# 51 Mfg By sigma
USP Lot # LRAD2790
Sequence: L006_04282023_Adapalene_01
Purity Factor 0.998
Instrument ID: L006 Exp. Date Current Lot

Preparation of Standard
Name Adapalene
Wt. of Standard (mg) 25.01
Stock Solution -1
Dilution (mL) 25
Vol. taken (mL) 1.0 Stock Solution -2 for
Dilution (mL) 100 Level-1

Calibration Solutions Adapalene


Volume of Standard Stock Solution -2 3000000
Sample ID Dilution(mL) Concentration (µg/mL) Area
taken (mL) 2500000
Level - 1 5.00 50 0.998 32180
2000000
Level - 2 0.50 50 9.984 339126
Level - 3 1.0 50 19.968 667725 1500000

Area
Level - 4 2.0 50 39.936 1338908 1000000
Level - 5 3.0 50 59.904 2029019
500000
Level - 6 4.0 50 79.872 2699342
0
Slope 33833.89143 0.000 20.000 40.000 60.000 80.000 100.000
Intercept -3535.87257 Conc. (µg/mL
CC (R ) 0.99999

Adapalene
Volume of stock taken
Sample ID Dilution(mL) Response Solubility (µg/mL) Solubility (mg/mL)
(mL)
0.05% Adapalene-1 0.5 hr 1.0 1.00 23184 0.790 0.001
0.05% Adapalene- 2 0.5 hr 1.0 1.00 29588 0.979 0.001
0.05% Adapalene-3 0.5 hr 1.0 1.00 35335 1.149 0.001
0.05% Adapalene-1 1 hr 1.0 1.00 62698 1.958 0.002
0.05% Adapalene- 2 1 hr 1.0 1.00 70325 2.183 0.002
0.05% Adapalene-3 1 hr 1.0 1.00 73693 2.283 0.002
0.05% Adapalene-1 1.5 hr 1.0 1.00 95626 2.931 0.003
0.05% Adapalene- 2 1.5 hr 1.0 1.00 100925 3.087 0.003
0.05% Adapalene-3 1.5 hr 1.0 1.00 102721 3.141 0.003
0.05% Adapalene-1 2 hr 1.0 1.00 124912 3.796 0.004
0.05% Adapalene- 2 2 hr 1.0 1.00 126498 3.843 0.004
0.05% Adapalene-3 2 hr 1.0 1.00 129746 3.939 0.004
0.05% Adapalene-1 2.5 hr 1.0 1.00 144277 4.369 0.004
0.05% Adapalene- 2 2.5 hr 1.0 1.00 142840 4.326 0.004
0.05% Adapalene-3 2.5 hr 1.0 1.00 146409 4.432 0.004
0.05% Adapalene-1 3 hr 1.0 1.00 161101 4.866 0.005
0.05% Adapalene- 2 3 hr 1.0 1.00 152541 4.613 0.005
0.05% Adapalene-3 3 hr 1.0 1.00 159738 4.826 0.005
0.05% Adapalene-1 4 hr 1.0 1.00 187205 5.638 0.006
0.05% Adapalene- 2 4 hr 1.0 1.00 172582 5.205 0.005
0.05% Adapalene-3 4 hr 1.0 1.00 189001 5.691 0.006
0.05% Adapalene-1 5 hr 1.0 1.00 199330 5.996 0.006
0.05% Adapalene- 2 5 hr 1.0 1.00 182466 5.498 0.005
0.05% Adapalene-3 5 hr 1.0 1.00 203124 6.108 0.006
0.05% Adapalene-1 6 hr 1.0 1.00 204048 6.135 0.006
0.05% Adapalene- 2 6 hr 1.0 1.00 186721 5.623 0.006
0.05% Adapalene-3 6 hr 1.0 1.00 212514 6.386 0.006
0.1% Adapalene-1 0.5 hr 1.0 1.00 36626 1.187 0.001
0.1% Adapalene- 2 0.5 hr 1.0 1.00 33632 1.099 0.001
0.1% Adapalene-3 0.5 hr 1.0 1.00 41284 1.325 0.001
0.1% Adapalene-1 1 hr 1.0 1.00 111908 3.412 0.003
0.1%Adapalene- 2 1 hr 1.0 1.00 102633 3.138 0.003
0.1% Adapalene-3 1 hr 1.0 1.00 108464 3.310 0.003
0.1% Adapalene-1 1.5 hr 1.0 1.00 190006 5.720 0.006
0.1% Adapalene- 2 1.5 hr 1.0 1.00 170742 5.151 0.005
0.1% Adapalene-3 1.5 hr 1.0 1.00 173378 5.229 0.005
0.1% Adapalene-1 2 hr 1.0 1.00 258861 7.755 0.008
0.1% Adapalene- 2 2 hr 1.0 1.00 226244 6.791 0.007
0.1% Adapalene-3 2 hr 1.0 1.00 226635 6.803 0.007
0.1% Adapalene-1 2.5 hr 1.0 1.00 314720 9.406 0.009
0.1% Adapalene- 2 2.5 hr 1.0 1.00 271533 8.130 0.008
0.1% Adapalene-3 2.5 hr 1.0 1.00 271436 8.127 0.008
0.1% Adapalene-1 3 hr 1.0 1.00 361432 10.787 0.011
0.1% Adapalene- 2 3 hr 1.0 1.00 304774 9.112 0.009
0.1% Adapalene-3 3 hr 1.0 1.00 305665 9.139 0.009
0.1% Adapalene-1 4 hr 1.0 1.00 433167 12.907 0.013
0.1% Adapalene- 2 4 hr 1.0 1.00 362610 10.822 0.011
0.1% Adapalene-3 4 hr 1.0 1.00 367813 10.976 0.011
0.1% Adapalene-1 5 hr 1.0 1.00 464817 13.843 0.014
0.1% Adapalene- 2 5 hr 1.0 1.00 404971 12.074 0.012
0.1% Adapalene-3 5 hr 1.0 1.00 414413 12.353 0.012
0.1% Adapalene-1 6 hr 1.0 1.00 479825 14.286 0.014
0.1% Adapalene- 2 6 hr 1.0 1.00 430437 12.827 0.013
0.1% Adapalene-3 6 hr 1.0 1.00 434468 12.946 0.013
0.3% Adapalene RLD-1 0.5 hr 1.0 1.00 119651 3.641 0.004
0.3% Adapalene RLD- 2 0.5 hr 1.0 1.00 126630 3.847 0.004
0.3% Adapalene RLD-3 0.5 hr 1.0 1.00 93217 2.860 0.003
0.3% Adapalene RLD-1 1 hr 1.0 1.00 354322 10.577 0.011
0.3% Adapalene RLD 2 1 hr 1.0 1.00 374956 11.187 0.011
0.3% Adapalene RLD-3 1 hr 1.0 1.00 292539 8.751 0.009
0.3% Adapalene RLD-1 1.5 hr 1.0 1.00 560338 16.666 0.017
0.3% Adapalene RLD- 2 1.5 hr 1.0 1.00 602980 17.926 0.018
0.3% Adapalene RLD-3 1.5 hr 1.0 1.00 483659 14.400 0.014
0.3% Adapalene RLD-1 2 hr 1.0 1.00 697779 20.728 0.021
0.3% Adapalene RLD- 2 2 hr 1.0 1.00 759867 22.563 0.023
0.3% Adapalene RLD-3 2 hr 1.0 1.00 608444 18.088 0.018
0.3% Adapalene RLD-1 2.5 hr 1.0 1.00 821182 24.375 0.024
0.3% Adapalene RLD- 2 2.5 hr 1.0 1.00 885807 26.286 0.026
0.3% Adapalene RLD 3 2.5 hr 1.0 1.00 728817 21.646 0.022
0.3% Adapalene RLD-1 3 hr 1.0 1.00 913231 27.096 0.027
0.3% Adapalene RLD 2 3 hr 1.0 1.00 975030 28.923 0.029
0.3% Adapalene RLD -3 3 hr 1.0 1.00 816377 24.233 0.024
0.3% Adapalene RLD-1 4 hr 1.0 1.00 1060171 31.439 0.031
0.3% Adapalene RLD - 2 4 hr 1.0 1.00 1124648 33.345 0.033
0.3% Adapalene RLD-3 4 hr 1.0 1.00 971771 28.826 0.029
0.3% Adapalene RLD-1 5 hr 1.0 1.00 1142104 33.861 0.034
0.3% Adapalene RLD- 2 5 hr 1.0 1.00 1225773 36.334 0.036
0.3% Adapalene RLD-3 5 hr 1.0 1.00 1073414 31.831 0.032
0.3% Adapalene RLD-1 6 hr 1.0 1.00 1190892 35.303 0.035
0.3% Adapalene RLD- 2 6 hr 1.0 1.00 1270810 37.665 0.038
0.3% Adapalene RLD-3 6 hr 1.0 1.00 1138516 33.755 0.034
Name: Adapalene/Benzoylperoxide - IVRT
Protocol: AMVP-0171-R00
Test: IVRT_BPO
LNB Ref AD0252 Pg# 36

Chemicals Used
Name Mfg. Lot # In-house # Exp. Date
Acetonitrile J.T. Baker 21K2862002 C/0043/23 11/2026
Membrane (Nylon) Innovetree ASC000I09065MF NA NA
Elga water NA NA NA NA

Equipments
Name Equipment ID Cal. Due Date
Teledyne Hanson (Agilent cells) L137 01/2024
Autopipette L180 03/2024
Balance L052 08/2023
Thermometer L117 03/2024
Paddle height adjustment (ball) L198 06/2024
Elga water System L024 01/2024

Sample Detials
S.No. Sample Name Manufacturer In-house # Lot# Expiry date
1 Adapalene/BPO 0.3%/2.5% Adalvo CSG237/23 E0311 NA

Study Parameters
Temperature 32oC
Volume 50 mL
Speed 30 rpm
Sampling volume 1.0 mL
Membrane 25mm diameter Nylon membrane (0.45µm)
Receiver Media 60:40 Acetonitrile:Water (%v/v)
Sample wt./ Dose 300 mg
No. of Replicates 6

Cell No.
1 2 3 4 5 6
Dose (mg)
Dose time
Sampling time points
1.0 Time
1.5 Time
2.0 Time
2.5 Time
3.0 Time
4.0 Time
5.0 Time
6.0 Time
Name: Adapalene/Benzoylperoxide - IVRT
Protocol: AMVP-0171-R00
Test: IVRT_BPO
LNB Ref AD0252 Pg#44

Chemicals Used
Name Mfg. Lot # In-house # Exp. Date
Acetonitrile J.T. Baker 21K2862002 C/0043/23 11/2026
Membrane (Nylon) Innovetree ASC000I09065MF NA NA
Elga water NA NA NA NA

Equipments
Name Equipment ID Cal. Due Date
Teledyne Hanson (Agilent cells) L137 01/2024
Autopipette L180 03/2024
Balance L052 08/2023
Thermometer L117 03/2024
Paddle height adjustment (ball) L198 06/2024
Elga water System L024 01/2024

Sample Detials
S.No. Sample Name Manufacturer In-house # Lot# Expiry date
1 Adapalene/BPO 0.3%/2.5% Adalvo CSG237/23 E0311 NA

Study Parameters
Temperature 32oC
Volume 50 mL
Speed 30 rpm
Sampling volume 1.0 mL
Membrane 25mm diameter Nylon membrane (0.45µm)
Receiver Media 60:40 Acetonitrile:Water (%v/v)
Sample wt./ Dose 300 mg
No. of Replicates 6

Cell No.
1 2 3 4 5 6
Dose (mg)
Dose time
Sampling time points
1.0 Time
1.5 Time
2.0 Time
2.5 Time
3.0 Time
4.0 Time
5.0 Time
6.0 Time
The assessment of in vitro release study will be based upon 90% confidence intervals for the ratio of the means (Test/
parameters under consideration according the draft guideline on quality and equivalence of topical products (EMA, 20

The acceptance criteria for equivalence parameters

The assessment of in vitro release study will be based upon 90% confidence intervals for the ratio of the means (Test/
parameters under consideration according the draft guideline on quality and equivalence of topical products (EMA, 20
The acceptance criteria for equivalence parameters

1. The cumulative amount of active substance released versus the square root of time should be linear. The paramete
significantly different from zero.
2. The 90% confidence interval for the ratio of means of the test and comparator products for the parameters (R), (A
within the acceptance interval of 90 – 111%.

3. Lag times should be the same (i.e.within ±10%), if present


the ratio of the means (Test/Comparator) for the
of topical products (EMA, 2018).

the ratio of the means (Test/Comparator) for the


of topical products (EMA, 2018).

ould be linear. The parameter R should be

s for the parameters (R), (A) should be contained


Drug Release Rate
Cumulative Amount
Cell# (µg/cm2*h-0.5) Lag Time (Sqrt Hour)
Released (µg) (A)
(R)

Cell-1 220.71 498.48 -0.82


R: Drug Release Rate (µg/cm2*h-0.5)
Cell-2 204.45 486.19 -0.90
A: Cumulative Amout Release (µg)
Cell-3 226.41 478.02 -0.83
Lag Time : sqrt time in h
Cell-4 215.57 487.45 -0.88

EPIDUO Gel, 0.1%/2.5% Cell-4 215.66 488.05 -0.86


(LOT# 2324270)
R1 Cell-6 206.92 494.05 -0.84

Cell-7 201.91 466.66 -0.99

Cell-8 201.16 486.90 -1.01

Cell-9 211.99 466.21 -0.99

Cell-10 199.73 462.37 -1.00

Cell-11 192.22 498.83 -0.99

m
C

A
u

n
a

o
e
t
l

i
0
f(x) = NaN x + NaN
R ² = 0 0.80 1.00 1.

Cell-12 190.01 475.16 -0.99

Cell-1 192.61 455.91 -1.01

Cell-2 187.01 447.75 -0.97

Cell-3 215.81 482.45 -0.80

Cell-4 206.71 447.10 -1.01

Cell-4 207.77 473.86 -0.80

ADP/BPO Gel, 0.1%/2.5% Cell-6 206.57 457.55 -1.03


(LOT# E0300)
T1 Cell-7 199.39 466.66 -0.89

Cell-8 195.09 486.90 -0.81

Cell-9 199.87 466.21 -0.98

Cell-10 197.28 462.37 -0.93

Cell-11 207.37 498.83 -0.79

Cell-12 206.29 475.16 -0.93

Cell-1 204.11 457.61 -1.01

Cell-2 206.40 461.98 -1.01

Cell-3 202.74 441.83 -1.06

Cell-4 203.70 451.91 -1.06

Cell-4 200.00 438.79 -1.02

EPIDUO Gel, 0.1%/2.5% Cell-6 195.55 434.70 -1.03


(LOT# 2324257)
R2 Cell-7 221.19 498.69 -0.91

Cell-8 217.04 475.72 -0.86

Cell-9 210.83 453.69 -0.98

Cell-10 210.41 460.55 -0.98

Cell-11 204.20 446.95 -0.98

Cell-12 200.92 436.75 -1.05

Cell-1 212.54 483.47 -0.84

ADP/BPO Gel, 0.1%/2.5%


(LOT# E0303)
T2
Drug Release Rate
Cumulative Amount Released
Cell# (µg/cm2*h-0.5) Lag Time (Sqrt Hour)
(µg) (A)
(R)

Cell-1 1848.09 6642.69 -0.57


R: Drug Release Rate (µg/cm2*h-0.5)
Cell-2 1653.22 6362.55 -0.57
A: Cumulative Amout Release (µg)
Cell-3 1616.12 6803.93 -0.55
Lag Time : sqrt time in h
Cell-4 1542.28 6573.86 -0.47

Cell-4 1692.76 6794.44 -0.56


EPIDUO Gel, 0.1%/2.5%
(LOT# 2324270)
R1 Cell-6 1705.17 6700.12 -0.48

Cell-7 1773.32 6399.64 -0.67

Cell-8 1763.73 6445.98 -0.65

Cell-9 1707.56 6205.98 -0.68

Cell-10 1678.88 6171.40 -0.68

Cell-11 1739.70 6245.46 -0.66

m
C

A
u

n
a

o
e
t

t
l

i
0
f(x ) = N a N x + N a N
0 .8 0 1 .0 0 1 .2 0
R ² = 0

Cell-12 1681.20 6024.93 -0.63

Cell-1 1711.95 6180.95 -0.55

Cell-2 1733.15 6800.03 -0.52

Cell-3 1724.89 6453.20 -0.53

Cell-4 1774.72 6936.67 -0.55

Cell-4 1812.55 6506.93 -0.57

ADP/BPO Gel, 0.1%/2.5% Cell-6 1799.98 6582.55 -0.52


(LOT# E0300)
T1 Cell-7 1776.57 6152.84 -0.69

Cell-8 1682.14 5868.93 -0.70

Cell-9 1729.80 6095.95 -0.66

Cell-10 1802.67 6230.05 -0.71

Cell-11 1678.16 6180.92 -0.71

Cell-12 1694.98 5844.05 -0.69

Cell-1 1933.96 6719.87 -0.61

Cell-2 1870.90 6657.46 -0.59

Cell-3 1813.59 6421.00 -0.64

Cell-4 1796.70 6109.38 -0.63

Cell-4 1803.71 6387.27 -0.64

EPIDUO Gel, 0.1%/2.5% Cell-6 1800.67 6454.42 -0.61


(LOT# 2324257)
R2 Cell-7 1840.42 6447.06 -0.67

Cell-8 1815.89 6543.07 -0.63

Cell-9 1818.93 6429.34 -0.68

Cell-10 1845.74 6444.06 -0.69

Cell-11 1790.88 6376.68 -0.66

Cell-12 1819.73 6339.01 -0.67

Cell-1 1870.13 6579.55 -0.70

ADP/BPO Gel, 0.1%/2.5%


(LOT# E0303)
T2
Name: Determination of Benzoyl peroxide from IVRT by HPLC
Test: IVRT
Standard Details
Details of Instrumemnt Name Benzoyl peroxide
Date: 4/28/2023 In-house Lot # C/0052/23
LNB Ref #: AD0206, Page# 51 Mfg By sigma
USP Lot # S8297041246
Sequence: L006_04282023_Adapalene_01
Purity Factor 0.75
Instrument ID: L006 Exp. Date Apr-26

Preparation of Standard
Name Adapalene
Wt. of Standard (mg) 333.80
Stock Solution -1
Dilution (mL) 25
Vol. taken (mL) 1.0 Stock Solution -2 for
Dilution (mL) 100 Level-1

Calibration Solutions BPO


Volume of Standard Stock Solution -2 1600000
Sample ID Dilution(mL) Concentration (µg/mL) Area
taken (mL) 1400000
Level - 1 0.50 100 0.501 1430 1200000

Level - 2 0.50 100 50.070 135620 1000000

Level - 3 1.0 100 100.140 268868 800000

Area
Level - 4 2.0 100 200.280 536414 600000

Level - 5 100 400.560 1106050 400000


4.0
200000
Level - 6 5.0 100 500.700 1366787
0
Slope 2745.31458 0.000 100.000 200.000 300.000 400.000 500.000 600.000
Intercept -3775.65488 Conc. (µg/mL
CC (R ) 0.99992

Adapalene
Volume of stock taken
Sample ID Dilution(mL) Response Solubility (µg/mL) Solubility (mg/mL)
(mL)
RLD BPO-1 0.5 hr 1.0 1.00 371820 136.813 0.137
RLD BPO- 2 0.5 hr 1.0 1.00 337702 124.386 0.124
RLD BPO-3 0.5 hr 1.0 1.00 330867 121.896 0.122
RLDBPO-1 1 hr 1.0 1.00 1067436 390.196 0.390
RLDBPO- 2 1 hr 1.0 1.00 973709 356.056 0.356
RLDBPO-3 1 hr 1.0 1.00 915413 334.821 0.335
RLDBPO-1 1.5 hr 1.0 1.00 1245310 454.988 0.455
RLDBPO- 2 1.5 hr 1.0 1.00 1316474 480.910 0.481
RLDBPO-3 1.5 hr 1.0 1.00 1286705 470.067 0.470
RLDBPO-1 2 hr 1.0 1.00 1191618 435.430 0.435
RLDBPO- 2 2 hr 1.0 1.00 1281330 468.109 0.468
RLDBPO-3 2 hr 1.0 1.00 1257186 459.314 0.459
RLDBPO-1 2.5 hr 1.0 1.00 1151768 420.915 0.421
RLDBPO- 2 2.5 hr 1.0 1.00 1212093 442.889 0.443
RLDBPO-3 2.5 hr 1.0 1.00 1204582 440.153 0.440
RLDBPO-1 3 hr 1.0 1.00 1093140 399.559 0.400
RLDBPO- 2 3 hr 1.0 1.00 1144357 418.215 0.418
RLDBPO-3 3 hr 1.0 1.00 1134742 414.713 0.415
RLDBPO-1 4 hr 1.0 1.00 1028971 376.185 0.376
RLDBPO- 2 4 hr 1.0 1.00 1123146 410.489 0.410
RLDBPO-3 4 hr 1.0 1.00 1102868 403.103 0.403
RLDBPO-1 5 hr 1.0 1.00 979708 358.241 0.358
RLDBPO- 2 5 hr 1.0 1.00 1051363 384.342 0.384
RLDBPO-3 5 hr 1.0 1.00 1037104 379.148 0.379
RLDBPO-1 6 hr 1.0 1.00 923586 337.798 0.338
RLDBPO- 2 6 hr 1.0 1.00 988691 361.513 0.362
RLDBPO-3 6 hr 1.0 1.00 979988 358.343 0.358
Test BPO-1 0.5 hr 1.0 1.00 341659 125.827 0.126
Test BPO- 2 0.5 hr 1.0 1.00 300066 110.676 0.111
Test BPO-3 0.5 hr 1.0 1.00 325827 120.060 0.120
Test BPO-1 1 hr 1.0 1.00 966062 353.270 0.353
Test BPO- 2 1 hr 1.0 1.00 869164 317.974 0.318
Test BPO-3 1 hr 1.0 1.00 757488 277.296 0.277
Test BPO-1 1.5 hr 1.0 1.00 1274981 465.796 0.466
Test BPO- 2 1.5 hr 1.0 1.00 1311064 478.940 0.479
Test BPO-3 1.5 hr 1.0 1.00 1218975 445.395 0.445
Test BPO-1 2 hr 1.0 1.00 1226924 448.291 0.448
Test BPO- 2 2 hr 1.0 1.00 1326314 484.494 0.484
Test BPO-3 2 hr 1.0 1.00 1339606 489.336 0.489
Test BPO-1 2.5 hr 1.0 1.00 1173009 428.652 0.429
Test BPO- 2 2.5 hr 1.0 1.00 1266877 462.844 0.463
Test BPO-3 2.5 hr 1.0 1.00 1293934 472.700 0.473
Test BPO-1 3 hr 1.0 1.00 1114244 407.246 0.407
Test BPO- 2 3 hr 1.0 1.00 1210764 442.405 0.442
Test BPO-3 3 hr 1.0 1.00 1252180 457.491 0.457
Test BPO-1 4 hr 1.0 1.00 1077666 393.923 0.394
Test BPO- 2 4 hr 1.0 1.00 1160831 424.216 0.424
Test BPO-3 4 hr 1.0 1.00 1199123 438.164 0.438
Test BPO-1 5 hr 1.0 1.00 1033178 377.718 0.378
Test BPO- 2 5 hr 1.0 1.00 1113128 406.840 0.407
Test BPO-3 5 hr 1.0 1.00 1159203 423.623 0.424
Test BPO-1 6 hr 1.0 1.00 989895 361.951 0.362
Test BPO- 2 6 hr 1.0 1.00 1070036 391.143 0.391
Test BPO-3 6 hr 1.0 1.00 1103994 403.513 0.404
Name: Determination of Benzoyl peroxide from IVRT by HPLC
Test: IVRT
Standard Details
Details of Instrumemnt Name Benzoyl peroxide
Date: 4/23/2023 In-house Lot #
LNB Ref #: AD0206, Page# 42 to 44 Mfg By sigma
USP Lot # S8297041246
Sequence: L006_04212023_Adapalene_01
Purity Factor 0.75
Instrument ID: L006 Exp. Date

Preparation of Standard
Name Adapalene
Wt. of Standard (mg) 102.40
Stock Solution -1
Dilution (mL) 10
Vol. taken (mL) 0.5 Stock Solution -2 for
Dilution (mL) 5 Level-1

Calibration Solutions BPO


1200000
Volume of Standard Stock Solution -2
Sample ID Dilution(mL) Concentration (µg/mL) Area
taken (mL) 1000000

Level - 1 0.33 50 5.069 14065 800000


Level - 2 0.35 50 53.760 149441 600000

Area
Level - 3 1.0 50 153.600 430393
400000
Level - 4 2.0 50 307.200 874903
Level - 5 384.000 1140439 200000
2.5 50
Slope 2945.46711 0
0.000 100.000 200.000 300.000 400.000 500.000
Intercept -10473.69969 Conc. (µg/mL
CC (R ) 0.99945

Adapalene
Volume of stock taken
Sample ID Dilution(mL) Response Solubility (µg/mL) Solubility (mg/mL)
(mL)
C-1 0.5 hr 1.0 1.00 40056 17.155 0.017
C-2 0.5 hr 1.0 1.00 46712 19.415 0.019
C-3 0.5 hr 1.0 1.00 52925 21.524 0.022
C-4 0.5 hr 1.0 1.00 91208 34.521 0.035
C-5 0.5 hr 1.0 1.00 85679 32.644 0.033
C-6 0.5 hr 1.0 1.00 84082 32.102 0.032
C-7 0.5 hr 1.0 1.00 96286 36.245 0.036
C-8 0.5 hr 1.0 1.00 65405 25.761 0.026
C-9 0.5 hr 1.0 1.00 100518 37.682 0.038
C-1 1 hr 1.0 1.00 90714 34.354 0.034
C-2 1 hr 1.0 1.00 99490 37.333 0.037
C-3 1 hr 1.0 1.00 117202 43.347 0.043
C-4 1 hr 1.0 1.00 167520 60.430 0.060
C-5 1 hr 1.0 1.00 156111 56.556 0.057
C-6 1 hr 1.0 1.00 156989 56.854 0.057
C-7 1 hr 1.0 1.00 294776 103.634 0.104
C-8 1 hr 1.0 1.00 110197 40.968 0.041
C-9 1 hr 1.0 1.00 178620 64.198 0.064
C-1 1.5 hr 1.0 1.00 135410 49.528 0.050
C-2 1.5 hr 1.0 1.00 145572 52.978 0.053
C-3 1.5 hr 1.0 1.00 177399 63.784 0.064
C-4 1.5 hr 1.0 1.00 234801 83.272 0.083
C-5 1.5 hr 1.0 1.00 216636 77.105 0.077
C-6 1.5 hr 1.0 1.00 219618 78.117 0.078
C-7 1.5 hr 1.0 1.00 408715 142.317 0.142
C-8 1.5 hr 1.0 1.00 153566 55.692 0.056
C-9 1.5 hr 1.0 1.00 238743 84.610 0.085
C-1 2 hr 1.0 1.00 183821 65.964 0.066
C-2 2 hr 1.0 1.00 188429 67.528 0.068
C-3 2 hr 1.0 1.00 223218 79.339 0.079
C-4 2 hr 1.0 1.00 278086 97.967 0.098
C-5 2 hr 1.0 1.00 266172 93.923 0.094
C-6 2 hr 1.0 1.00 267318 94.312 0.094
C-7 2 hr 1.0 1.00 504843 174.952 0.175
C-8 2 hr 1.0 1.00 174537 62.812 0.063
C-9 2 hr 1.0 1.00 294288 103.468 0.103
C-1 2.5 hr 1.0 1.00 215677 76.779 0.077
C-2 2.5 hr 1.0 1.00 210612 75.060 0.075
C-3 2.5 hr 1.0 1.00 253982 89.784 0.090
C-4 2.5 hr 1.0 1.00 309711 108.704 0.109
C-5 2.5 hr 1.0 1.00 299153 105.120 0.105
C-6 2.5 hr 1.0 1.00 305700 107.342 0.107
C-7 2.5 hr 1.0 1.00 551580 190.820 0.191
C-8 2.5 hr 1.0 1.00 204230 72.893 0.073
C-9 2.5 hr 1.0 1.00 349208 122.114 0.122
C-1 3 hr 1.0 1.00 247669 87.641 0.088
C-2 3 hr 1.0 1.00 250669 88.659 0.089
C-3 3 hr 1.0 1.00 286965 100.982 0.101
C-4 3 hr 1.0 1.00 341580 119.524 0.120
C-5 3 hr 1.0 1.00 334738 117.201 0.117
C-6 3 hr 1.0 1.00 344111 120.383 0.120
C-7 3 hr 1.0 1.00 633547 218.648 0.219
C-8 3 hr 1.0 1.00 236611 83.886 0.084
C-9 3 hr 1.0 1.00 415856 144.741 0.145
C-1 4 hr 1.0 1.00 317372 111.305 0.111
C-2 4 hr 1.0 1.00 354726 123.987 0.124
C-3 4 hr 1.0 1.00 375354 130.990 0.131
C-4 4 hr 1.0 1.00 428845 149.151 0.149
C-5 4 hr 1.0 1.00 422985 147.161 0.147
C-6 4 hr 1.0 1.00 428906 149.171 0.149
C-7 4 hr 1.0 1.00 732018 252.079 0.252
C-8 4 hr 1.0 1.00 304822 107.044 0.107
C-9 4 hr 1.0 1.00 566131 195.760 0.196
C-1 5hr 1.0 1.00 383907 133.894 0.134
C-2 5hr 1.0 1.00 419675 146.038 0.146
C-3 5hr 1.0 1.00 437417 152.061 0.152
C-4 5hr 1.0 1.00 489871 169.869 0.170
C-5 5hr 1.0 1.00 481044 166.873 0.167
C-6 5hr 1.0 1.00 475909 165.129 0.165
C-7 5hr 1.0 1.00 727535 250.557 0.251
C-8 5hr 1.0 1.00 350041 122.396 0.122
C-9 5hr 1.0 1.00 625430 215.892 0.216

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