Atracurium Storage Requirements
Atracurium besylate injection requires refrigeration at 2°C to 8°C (36°F to 46°F) to preserve potency, but can be stored at room temperature for up to 14 days after removal from refrigeration. 1
Official Storage Guidelines
The FDA-approved drug label explicitly states that atracurium besylate injection should be refrigerated at 2°C to 8°C to preserve potency and must not be frozen. 1 Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), the product must be used within 14 days even if re-refrigerated. 1 This represents the manufacturer's official cold chain requirement.
Extended Stability Evidence
While the FDA label recommends 14 days at room temperature, research evidence suggests atracurium may remain stable for longer periods:
At room temperature (25°C): Atracurium besylate 10 mg/mL solutions stored in plastic syringes remained chemically stable for up to 6 weeks without significant drug loss. 2
Refrigerated storage (5°C): Significantly improved drug stability compared to room temperature storage. 2
The manufacturer's recommended expiry period appears conservative based on stability-indicating HPLC analysis. 2
Practical Implications
The cold chain requirement exists primarily to maximize shelf life and maintain optimal potency over extended periods. 1 The unique metabolism of atracurium through Hofmann elimination and ester hydrolysis (which are temperature-dependent processes) means the drug degrades faster at higher temperatures. 3, 4
Key Storage Considerations:
Protect from light: Vials should be kept in cartons until time of use. 1
Do not freeze: Freezing is contraindicated and may damage the formulation. 1
14-day rule: Once removed from refrigeration, the drug must be used within 14 days regardless of whether it is returned to refrigeration. 1
Transport: For critical care transport, atracurium is listed among neuromuscular blocking agents that should be added immediately before transport as indicated, suggesting room temperature transport is acceptable for short durations. 3
Clinical Context
Unlike some medications that absolutely require continuous cold chain (such as certain vaccines that lose potency irreversibly when exposed to improper temperatures 3), atracurium has a more forgiving stability profile at room temperature for limited periods. 2 However, adherence to the FDA-approved 14-day room temperature limit ensures consistent drug potency and patient safety. 1