API form-definition
API form. Sales in 2020 kg duloxetine hydrochloride 816,59557281 duloxetine 727,4225603* *calculated by multiplying the kg of duloxetine hydrochloride sold by the molecular weight ratio of duloxetine free base:duloxetine hydrochloride salt (297.42:333.88) R = Assumed 0% removal rate in a sewage treatment plant P = 9000000 population of Sweden V = 200 litre of wastewater per capita per day (default from ECHA, 2012) D = 10 dilution of wastewater by surface water flow (default from ECHA, 2012) The Swedish Environmental Research Institute has conducted a national screening program for 101 pharmaceuticals in urban wastewater treatment plants and their receiving waters (Fick et al 2011, 2015). Samples of wastewater treatment plant influent and effluent (total of 39 samples) were analyzed and 11 samples had measurable levels of duloxetine. The measured concentrations of duloxetine ranged from 0.001 to 0.014 µg/l, with a mean concentration of 0.007 µg/l. In surface water no samples had detectable levels of duloxetine, even those downstream of wastewater treatment plant effluents (the limit of quantitation was 0.001 µg/l). The data reported by ▇▇▇▇ et al (2011, 2015) are in agreement with previous reports of duloxetine concentrations in U.S. wastewater effluents and receiving surface waters (levels were less than 0.005 and 0.002 µg/l, respectively) in that detections are infrequent and levels are less than 0.01 µg/l (▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ 2008; ▇▇▇▇▇▇▇ et al 2010). Therefore, the calculated PEC of 0.1 µg/l is greater than actual measured concentrations detected in surface water. Nonetheless, the PEC of 0.1 µg/l will be used to assess the environmental risk.
API form. Sales in 2020 kg fluoxetine hydrochloride 329,2698376038 fluoxetine 294,5516728* *calculated by multiplying the kg of fluoxetine hydrochloride sold by the molecular weight ratio of fluoxetine free base:fluoxetine hydrochloride salt (309.33:345.79) R = Assumed 0% removal rate in a sewage treatment plant P = 9000000 population of Sweden V = 200 L of wastewater per capita per day (default from ECHA, 2012) D = 10 dilution of wastewater by surface water flow (default from ECHA, 2012) Barclay et al (2012) have reported concentrations of fluoxetine and its major metabolite, norfluoxetine, in raw and treated waste water in Uppsala, Sweden that ranged from 0.001 to 0.016 µg/l. The Swedish Environmental Research Institute has conducted a national screening program for 101 pharmaceuticals in urban wastewater treatment plants and their receiving waters (Fick et al 2011, 2015). In 2010, samples of wastewater treatment plant influent and effluent (total of 24 samples) were analyzed and 21 samples had measurable levels of fluoxetine ranging from 0.005 to 0.240 µg/l, with a mean concentration of 0.041 µg/l and a median concentration of 0.017 µg/l. In 2014, samples of wastewater treatment plant influent and effluent (total of 15 samples) were analyzed and 7 had measurable levels of fluoxetine ranging from 0.0051 to 0.024 μg/l, with a mean concentration of 0.012 μg/l and a median concentration of 0.010 μg/l. In the river that received effluent from the Uppsala WWTP, fluoxetine was detected in both 2010 and 2014 at 0.032 and 0.0065 µg/l near the effluent outfall but only in 2010 150 m downstream (0.006 µg/l). Sampling points further downstream and in other surface waters did not have measurable levels (limit of quantitation was 0.005 µg/l). The surface water data reported by ▇▇▇▇ et al (2011, 2015) are in agreement with previous reports of detection of fluoxetine in surface water (▇▇▇▇▇▇ et al 2002; ▇▇▇▇▇▇ et al 2008; ▇▇▇▇▇▇▇▇▇▇ et al 2008; ▇▇▇▇▇▇▇▇ et al 2003; ▇▇▇▇ et al 2009) in that the detections are infrequent and the levels are less than 0.05 µg/l. Therefore, the calculated PEC of 0.06 µg/l is greater than actual measured concentrations detected in surface water. Nonetheless, the PEC of 0.06 µg/l will be used to assess the environmental risk.