[Study on the potential impact of bromomethane on medicinal products following simulated container fumigation]
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[Study on the potential impact of bromomethane on medicinal products following simulated container fumigation]. / Langfermann, C; Klementz, D; Sierts-Herrmann, A; Poschadel, Bernd; Sagunski, H; Hösch, C; Horn, K; Reichmuth, C; Baur, Xaver.
in: BUNDESGESUNDHEITSBLA, Jahrgang 50, Nr. 4, 4, 2007, S. 492-499.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - [Study on the potential impact of bromomethane on medicinal products following simulated container fumigation]
AU - Langfermann, C
AU - Klementz, D
AU - Sierts-Herrmann, A
AU - Poschadel, Bernd
AU - Sagunski, H
AU - Hösch, C
AU - Horn, K
AU - Reichmuth, C
AU - Baur, Xaver
PY - 2007
Y1 - 2007
N2 - To protect against exotic forest pest, solid wood packing has to be treated before shipping. According to the international standard ISPM 15 containers are usually fumigated with bromomethane. During this quarantine treatment a chemical reaction of bromomethane with the transported goods can not principally be excluded. This study takes a look at the impact of bromomethane on selected potential sensitive active pharmaceutical ingredients during simulated container fumigation. Following a 24-hour exposure to 67-80 g bromomethane per cubic meter, up to 0.02% bromide has been confirmed in phenacetine. The bromide concentrations in other active pharmaceutical ingredients were below 0.002%. New reaction products have not been identified at a detection limit of 0.01-0.04%. The bromide residue detected in one active pharmaceutical ingredient does not represent a relevant impairment of quality according to the European Pharmacopoeia, nor does it lead to a relevant excess exposure compared to both the acceptable daily intake of bromide and to the actual daily uptake of bromide from other exposure paths, dominantly from food consumption.
AB - To protect against exotic forest pest, solid wood packing has to be treated before shipping. According to the international standard ISPM 15 containers are usually fumigated with bromomethane. During this quarantine treatment a chemical reaction of bromomethane with the transported goods can not principally be excluded. This study takes a look at the impact of bromomethane on selected potential sensitive active pharmaceutical ingredients during simulated container fumigation. Following a 24-hour exposure to 67-80 g bromomethane per cubic meter, up to 0.02% bromide has been confirmed in phenacetine. The bromide concentrations in other active pharmaceutical ingredients were below 0.002%. New reaction products have not been identified at a detection limit of 0.01-0.04%. The bromide residue detected in one active pharmaceutical ingredient does not represent a relevant impairment of quality according to the European Pharmacopoeia, nor does it lead to a relevant excess exposure compared to both the acceptable daily intake of bromide and to the actual daily uptake of bromide from other exposure paths, dominantly from food consumption.
M3 - SCORING: Zeitschriftenaufsatz
VL - 50
SP - 492
EP - 499
JO - BUNDESGESUNDHEITSBLA
JF - BUNDESGESUNDHEITSBLA
SN - 1436-9990
IS - 4
M1 - 4
ER -
