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Stability of VELETRI
Last Updated: 08/20/2026
SUMMARY
- The stability and preservation of reconstituted and fully diluted solutions of VELETRI for injection was evaluated under a range of storage conditions and is summarized below.1
- No information is available regarding the stability of VELETRI for injection when placed in a pneumatic tube or shaken.
CLINICAL DATA
The stability and preservation of reconstituted and fully diluted solutions of VELETRI for injection was evaluated under a range of storage conditions.1 Reconstituted VELETRI for injection was stable up to one day when stored at 77°F (25°C) or 7 days when stored at 41°F (5°C). Depending on the concentration and conditions studied, the authors describe the following results summarized in Table: Stability of Reconstituted and Fully Diluted VELETRI for Injection Solutions, Expressed in Terms of Potency (Relative to Initial Potency at Time Zero), When Exposed to Temperatures Between 77°F (25°C) and 104°F (40°C), Table: Stability of Diluted Solutions of VELETRI for Injection Stored for 24 or 48 Hours at 77°F (25°C) or 86°F (30°C), After Reconstitution and Storage at 41°F (5°C) for 8 Days, Table: Shelf-lives and Storage Conditions for VELETRI for Injection for Clinical Administration After Several Days of Storage of the Reconstituted Solution, and Table: Shelf-lives and Storage Conditions for VELETRI for Injection for Clinical Administration After Several Days of Storage of the Diluted Solution below.1
| Concentration | Time Exposed | Temperature | Potency |
|---|---|---|---|
| 3000 ng/mL | 48 hours | 77°F (25°C) | >90% |
| 24 hours | 86°F (30°C) | >90% | |
| 8 hours | 104°F (40°C) | >90% | |
| 15,000 ng/mL | 72 hours | 77°F (25°C) | >90% |
| 24 hours | 86°F (30°C) | >90% | |
| 12 hours | 104°F (40°C) | >90% | |
| 60,000 ng/mL | 72 hours | 77°F (25°C) | >90% |
| 48 hours | 86°F (30°C) | >90% | |
| 24 hours | 104°F (40°C) | >90% |
| Concentration | Time Exposed at 77°F (25°C) or 86°F (30°C) | Potency |
|---|---|---|
| 3000 ng/mL | 24 hours | >90% |
| 15,000 ng/mL | 24 hours | >92% |
| 60,000 ng/mL | 24 hours | >95% |
| 48 hours | >93% |
| Concentration | Condition of Storage of Reconstituted Solution | Maximum Shelf-life of Diluted Solution |
|---|---|---|
| ≥ 3000 ng/mL and < 15,000 ng/mL | 7 days at 41°F (5°C) OR 1 day at 77°F (25°C) | 24 hours at 77°F (25°C)a |
| 12 hours at 86°F (30°C)a | ||
| 8 hours at 104°F (40°C) | ||
| ≥ 15,000 ng/mL and < 60,000 ng/mL | 7 days at 41°F (5°C) OR 1 day at 77°F (25°C) | 48 hours at 77°F (25°C)a |
| 24 hours at 86°F (30°C)a | ||
| 8 hours at 104°F (40°C) | ||
| ≥ 60,000 ng/mL | 7 days at 41°F (5°C) OR 1 day at 77°F (25°C) | 72 hours at 77°F (25°C)a |
| 48 hours at 86°F (30°C)a | ||
| 24 hours at 104°F (40°C) | ||
| aEach recommendation includes a short excursion at 40°C for up to 2 hours for concentration below 15,000 ng/mL, up to 4 hours for a concentration between 15,000 ng/mL and 60,000 ng/mL and up to 8 hours for concentration above 60,000 ng/mL. | ||
| Concentration | Condition of Storage of Diluted Solution | Maximum Shelf-life of Diluted Solution |
|---|---|---|
| ≥ 3000 ng/mL and < 15,000 ng/mL | ≤ 8 days at 41°F (5°C) | 24 hours at 77°F (25°C)a |
| 24 hours at 86°F (30°C)a | ||
| ≥ 15,000 ng/mL and < 60,000 ng/mL | ≤ 8 days at 41°F (5°C) | 48 hours at 77°F (25°C)a |
| 24 hours at 86°F (30°C)a | ||
| ≥ 60,000 ng/mL | ≤ 8 days at 41°F (5°C) | 48 hours at 77°F (25°C)a |
| 48 hours at 86°F (30°C)a | ||
| aEach recommendation includes a short excursion at 40°C for up to 2 hours for concentration below 15,000 ng/mL, up to 4 hours for a concentration between 15,000 ng/mL and 60,000 ng/mL and up to 8 hours for concentration above 60,000 ng/mL. | ||
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Lambert O, Bandilla D. Stability and preservation of a new formulation of epoprostenol sodium for treatment of pulmonary arterial hypertension. Drug Des Devel Ther. 2012; 6:235-244. |
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