How is Halocarbons sevoflurane packaged?
Halocarbon’s sevoflurane is packaged in 250 ml USP Type III amber glass containers with a water content of not more than 70 parts per million (ppm). In order to receive FDA approval, a drug’s manufacturer must demonstrate its product’s stability in the sale container. Data submitted to the FDA showed Halocarbon’s sevoflurane in glass bottles was stable under standard accelerated conditions (bottles stored at 40ºC and 75% relative humidity for 3 months). Halocarbon also submitted data that showed its sevoflurane in glass bottles was stable under even more stressful hotter and drier conditions (60 ºC and less than 5% relative humidity for 3 months). Halocarbon’s stability testing and other research has produced no evidence that storing sevoflurane in type III glass results in Lewis Acid formation or otherwise contributes to decomposition of sevoflurane, or that the addition of water is necessary to promote stability.
Halocarbon’s sevoflurane is packaged in 250 ml USP Type III amber glass containers with a water content of not more than 70 parts per million (ppm). In order to receive FDA approval, a drug’s manufacturer must demonstrate its product’s stability in the sale container. Data submitted to the FDA showed Halocarbon’s sevoflurane in glass bottles was stable under standard accelerated conditions (bottles stored at 40ºC and 75% relative humidity for 3 months). Halocarbon also submitted data that showed its sevoflurane in glass bottles was stable under even more stressful hotter and drier conditions (60ºC and less than 5% relative humidity for 3 months). Halocarbon’s stability testing and other research has produced no evidence that storing sevoflurane in type III glass results in Lewis Acid formation or otherwise contributes to decomposition of sevoflurane, or that the addition of water is necessary to promote stability.
