[Study on the potential impact of bromomethane on medicinal products following simulated container fumigation].
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.
Langfermann
C
C
AMI Arzneimitteluntersuchungsinstitut-Nord GmbH, Bremen, BRD.
Klementz
D
D
Sierts-Herrmann
A
A
Poschadel
B
B
Sagunski
H
H
Hösch
C
C
Horn
K
K
Reichmuth
C
C
Baur
X
X
D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D004785:Environmental Pollutants / Q000032:analysis* / Q000737:chemistry*; D005651:Fumigation / Q000379:methods*; D006842:Hydrocarbons, Brominated / Q000032:analysis / Q000737:chemistry*; D007306:Insecticides / Q000032:analysis / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry*
D004785:Environmental Pollutants; D006842:Hydrocarbons, Brominated; D007306:Insecticides; D004364:Pharmaceutical Preparations; C005218:methyl bromide