Table 3.
Stability of the derivatized clopidogrel active metabolite (CAM-D) was evaluated at a concentration 100 ng/mL for ≤ 1 week (wk) stability, 4 months (mo) stability, and 9 mo stability. Stability of clopidogrel was evaluated at concentrations of 38.3 ng/mL for ≤ 1 wk stability and 76.6 ng/mL for 4 and 9 mo stability. Stability of clopidogrel carboxylic acid were evaluated at concentrations of 500 ng/mL for ≤ 1 wk stability and 2,500 ng/mL for 4 and 9 mo stability. Short term stability was assessed for up to 1 wk at room temperature (RT), 4°C, −20°C, or −80°C in citrate or EDTA treated feline plasma and up to 9 months (mo) at −80°C in citrate treated feline plasma. Long term stability at −80°C was not determined (ND) for EDTA treated feline plasma. Data are presented as percent deviation from the nominal concentration.
| Deviation from nominal concentration (%) | |||||||
|---|---|---|---|---|---|---|---|
| Citrate treated plasma
|
EDTA treated plasma
|
||||||
| Storage | Time | CAM-D | Clopidogrel | Clopidogrel carboxylic acid | CAM-D | Clopidogrel | Clopidogrel carboxylic acid |
| −10 | 10 | 4 | −2 | −4 | −11 | ||
| −10 | 6 | 9 | 1 | −2 | 3 | ||
| RT | 24 h | −5 | 7 | 14 | 5 | −2 | −2 |
| RT | 48 h | −17 | 7 | 20 | −4 | −5 | −10 |
| RT | 72 h | −20 | 0 | 17 | −3 | −1 | 1 |
| RT | 1 wk | −20 | 2 | 25 | −13 | 6 | −1 |
| 4°C | 6 h | 3 | 6 | 8 | −15 | −7 | −6 |
| 4°C | 12 h | 0 | 6 | 13 | 7 | 1 | 11 |
| 4°C | 24 h | −2 | 7 | 11 | 7 | −1 | −1 |
| 4°C | 48 h | 6 | 6 | 17 | 1 | 1 | −7 |
| 4°C | 72 h | 3 | 2 | 7 | 2 | −3 | −11 |
| 4°C | 1 wk | 7 | 6 | 19 | −2 | −10 | −15 |
| −20°C | 6 h | −5 | 7 | 0 | 4 | −6 | −6 |
| −20°C | 12 h | −9 | 7 | 18 | 6 | 0 | 10 |
| −20°C | 24 h | −9 | 6 | 10 | 6 | −2 | −1 |
| −20°C | 48 h | −4 | 6 | 16 | 0 | −2 | −6 |
| −20°C | 72 h | −16 | 5 | 8 | 2 | −5 | −1 |
| −20°C | 1 wk | −13 | 7 | 11 | 3 | −2 | 1 |
| −80°C | 6 h | 6 | 10 | 5 | 1 | −2 | −7 |
| −80°C | 12 h | −1 | 8 | 22 | 2 | −1 | −4 |
| −80°C | 24 h | 3 | 10 | 19 | 0 | 1 | −3 |
| −80°C | 48 h | 10 | 5 | 17 | 5 | −3 | −10 |
| −80°C | 72 h | −8 | 1 | 7 | 7 | 1 | −1 |
| −80°C | 1 wk | 1 | 2 | 15 | −1 | 1 | 1 |
| −80°C | 4 mo | 12 | 8 | 15 | ND | ND | ND |
| −80°C | 9 mo | −12 | 14 | −11 | ND | ND | ND |