| S. No |
Parameters |
Acceptance Criteria |
Results (%) |
| 1 |
Freeze and thaw cycle at -80°C |
Mean% change after 3 cycles
± 15% |
98.6-99.9 |
| 2 |
Bench top stability |
Mean% change after 10.14 h
± 15% |
100.8-102.3 |
| 3 |
Auto sampler stability |
Mean% change after 50.04 h:
85-115% |
102.10-102.3 |
| 4 |
Long term Stability |
Mean% change after 7 Days:
± 15% |
99.1-101.3 |
| 5 |
Stock solution stability at room temp. |
% Nominal concentration: ± 15% |
97.5 (Analyte) 103.3 (IS) |
| 6 |
Dilution integrity |
Accuracy (% Nominal ):
± 15%
Precision(%CV): ≤15% |
101.2
4.0 |
| 7 |
Matrix effect |
% CV ≤15% |
LQC 9.35
HQC 6.84 |
| 8 |
Ruggedness |
% Nominal: ± 15%
%CV: ≤15% |
107.1-111.4
1.8-4.7 |
