Table 11. Outcomes of stability studies of all three analytes .
|
Stability |
Analyte |
QC level |
Mean concentration of fresh stability sample |
Mean concentration of old comparison sample |
Stability % |
|
Bench top (6 hrs @ 25 °C) |
DOR |
LQC |
978 |
1107 |
88.35 |
|
HQC |
32625 |
34706 |
94.00 |
||
|
LAM |
LQC |
538 |
600 |
89.67 |
|
|
HQC |
12380 |
12339 |
100.33 |
||
|
TDF |
LQC |
149 |
178 |
83.71 |
|
|
HQC |
3231 |
3533 |
91.45 |
||
|
Long-term (6 hrs @ -20 °C) |
DOR |
LQC |
971 |
1198 |
81.05 |
|
HQC |
29103 |
32400 |
89.82 |
||
|
LAM |
LQC |
856 |
976 |
87.70 |
|
|
HQC |
13988 |
13561 |
103.15 |
||
|
TDF |
LQC |
172 |
163 |
105.52 |
|
|
HQC |
3654 |
3403 |
107.38 |
||
|
Short-term (25°C @ room temperature) |
DOR |
MQC |
3330 |
3261 |
102.12 |
|
LAM |
MQC |
17675 |
18421 |
95.95 |
|
|
TDF |
MQC |
25498 |
24958 |
102.16 |
DOR: Doravirine, LAM: Lamivudine, TDF: Tenofovir Disoproxil Fumarate, HQC: High-Quality Control, MQC: Middle-Quality Control, LQC: Low-Quality Control