| System suitability |
RSD % ≤ 0.85 for six consecutive
injections |
Complies (Table 4) |
| Specificity |
No interference from blank, placebo
or forced degradation related products between carglumic acid and
known impurities |
No interference observed (Table and5Figure 6) |
| Linearity and range |
|
R2 ≥
0.99 |
Complies |
|
P value |
≥0.05 for intercept |
| ≤0.05 for x value |
| Accuracy |
4 μg/mL (0.05%), 8000 μg/mL
(100%), 9600 μg/mL (120%) |
Should be within limit
98%–102% for each injection |
Complies (Table S10) |
| Precision |
RSD ≤ 2 N = 6each day, between days |
Complies (Tables S7 and S11–12) |
| LOD/LOQ |
LOQ s/N ≥
10 (RSD % ≤ 10 N = 6) |
x̅ s/N = 14.1 (RSD= 0.95) |
| LOD 2 ≤ s/N ≤ 3 |
s/N= 2.1, 2.2 |
