EA Review #1, NDA 20-358

Page 19

ATTACHMENT 4

TIER 1 – (Aquatic Compartment)

Attribute

Compound

Test Method

Compliance w/Protocol (Y/N)

Result

Comments

Aerobic Biodegradation in water

Bupropion Hydrochloride

EATAD 3.11

Yes

no degradation

Photodegradation

Bupropion hydrochloride

EATAD 3.10

Yes

pH 5 T_(unreadable) = 54

housrs pH 7 T_(unreadable)  = 30 hours (under experimental conditions)

Extrapolated T_(unreadable) in sunlight ranges from 23-592 hours

Microbial Growth Inhibition Testing

Bupropion hydrochloride

EATAD 4.02

Yes

No inhibition of azotobaceter chroococcum and pseudomonas fluorescens.  MIC of 1000 mg/L for Aspergillus flavus, chaetomium globosum and Nostoc sp.