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Allopurinol Takeda

Takeda Pharma

Tablett 100 mg
(Vita, runda med delskåra, 8,0 x 8,0 mm, prägling Nyco)

Medel mot gikt och hyperurikemi

Aktiv substans:
ATC-kod: M04AA01
Läkemedel från Takeda Pharma omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Allopurinol

Miljörisk: Risk för miljöpåverkan av allopurinol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att allopurinol är persistent, då data saknas.
Bioackumulering: Allopurinol har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental Risk Classification


Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A(100-R)

PEC = 0,79 μg/L

Where:

A = 5263,55 kg (total sold amount API in Sweden year 2018, data from IQVIA).

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 1)


Predicted No Effect Concentration (PNEC)

Data not available


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of allopurinol cannot be excluded, since there is not sufficient ecotoxicity data available.


Degradation

Data not available


Bioaccumulation

Partitioning coefficient:

The partitioning coefficient was determined in octanol-water or in octanol-0.05 M acetate buffer (pH 5.0) at 22°C. The aqueous phase and octanol were mutually saturated at 20-25°C before use. The compound was dissolved in the aqueous phase and the octanol-water mixture was shaken for 5-30 min to reach a distribution equilibrium. The volumes of each phase were chosen so that the solute concentration in the aqueous phase, before and after distribution, could readily be measured using the reversed-phase HPLC method. Centrifugation was used to separate the two phases.

The partition coefficients (P) were calculated from Eqn. 1:

P=(Ci – CW)/CW x VW/VO

where Ci and CW, represent the solute concentrations in the aqueous phase before and after distribution, respectively; VW represents the volume of the aqueous and VO, the volume of the octanol phase.


Log Pow = -0,55 (Ref. 2)

Since log Pow < 4, the substance has low potential for bioaccumulation.


References

1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

2. Bundgaard H, Falche E; Int J Pharm 23: 223-37 (1985)