ASCOR Shipping Conditions
We want to assure our customers that we can safely and effectively ship ASCOR® ascorbic acid injection (vitamin C) unrefrigerated, without ice packs in the shipment packaging, in these warm summer months.
If you receive ASCOR vials warm or even hot, please read the following technical details. They are the result of extensive stability testing and FDA review. We apologize if the following is overly technical, but we wanted to reassure our customers that we've done our due diligence.
The FDA has provided McGuff Pharmaceuticals, as the FDA-Approved New Drug Application (NDA) holder for ASCOR, vitamin C injection, the following labeling as found in the package insert.
"16. HOW SUPPLIED/STORAGE AND HANDLING…
Store in a refrigerator at 2° to 8°C (36° to 46°F).
Protect from light. This product contains no preservative. See Dosage and Administration (2.1), for detailed instructions on preparation, dilution, and administration of ASCOR. Excursions to ambient conditions for up to 30 days during storage or shipping are acceptable."
The statement “Excursions to ambient conditions for up to 30 days” refers to normal storage conditions, which typically involve storing the drug in a dry, clean, well-ventilated area at room temperatures. Specifically, this means maintaining temperatures between 15°C and 25°C (59°F to 77°F) or up to 30°C (86°F), depending on climatic conditions, for not more than 30 days.
Additionally, Mean Kinetic Temperature (MKT), is used to express the overall effect of temperature fluctuations during storage or shipping. MKT considers the cumulative impact of varying temperatures over time. For pharmaceuticals, excursions between 15°C and 30°C (59°F and 86°F) are allowed, provided the MKT does not exceed 25°C (77°F). Transient spikes up to 40°C (104°F) are permitted as long as they don’t exceed 24 hours, and spikes above 40°C may be allowed if the manufacturer instructs so.
In addition, McGuff ships all ASCOR to deliver in just three days or less.
McGuff remains compliant with all FDA industry guidelines, standards, and regulations regarding the distribution of ASCOR to provide the highest-quality ascorbic acid injection (vitamin C) product on the market.
Please contact us with any additional questions, concerns or to place your order. Our friendly customer service representatives are here to help! (800) 854-7220 | answers@mcguff.com.
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