Five degradation products were observed during the
study, four of which were more polar than the bupropion hydrochloride, i.e.,
eluted before the bupropion hydrochloride during reverse phase HPLC. The five degradation products, labeled A, B,
C, D and E, are believed to be 433C58, 852U77, 827U76, 377U68 and 20U78,
respectively, based upon their relative retention times (23). The polar degradation products, 433C58,
852U77, 827U76, and 20U78, contain the same backbone chemical structure of the
parent compound, bupropion hydrochloride.
The degradation product that was observed to be less polar than
bupropion hydrochloride, 377U78, is a possible process impurity and was
observed at levels <1% throughout the study. Detailed information on this test is provided in Attachment IV –
Aqueous Photodegradation Report. (NOT PROVIDED THROUGH FOI ACT)
LC50s (Microbial Inhibition): Nominal
concentrations of 000, 250, 62.5, 15.7, and 2.91 mg/L of the test chemical were
used as the established concentration range.
No inhibition was observed for the test organisms Axotobater
chrococcum and Pseudomonas fluorescens, at any of the established
test concentrations. The test organisms
Chaetomium globosum, Aspergillus flavus, and Nostoc sp.
indicated an (a) minumum inhibition concentration (MIC) value of
10000 mg/L. Detailed information on
this test is provided in Attachment V – Microbial Growth Inhibition Report. (NOT PROVIDED THROUGH FOI ACT)
LD50s:
|
Lethal Doses in Animals |
|
|
LD50
(male mice) |
544
mg/kg (20) |
|
LD50
(female mice) |
636
mg/kg (20) |
|
LD50
(male rat) |
607
mg/kg (20) |
|
LD50
(female rat) |
482
mg/kg (20) |
|
Intraperitonela
LD50 (rat) |
263
mg/kg (20) |
|
Oral
LD50 (rat) |
482
mg/kg (21) |
|
Intraperitoneal
LD50 (rat) |
200
mg/kg (22) |
|
Oral
LD50 (mouse) |
544
mg/kg (21) |
|
Intraperitoneal
LD50 (mouse) |
230
mg/kg (22) |
Detailed information on this test is provided in
Attachment I – Material Safety Data Sheet for Bupropion Hydrochloride and
Attachment VII – References. (NOT PROVIDED THROUGH FOI ACT)
GCPV/93/0011/03 26
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