Hydrolysis Rate
pH 5.0 aqueous buffer 2.95 X 10-10 sec-1
pH 7.4 aqueous buffer 4.80 X 10-7 sec-1
pH 9.0 aqueous buffer 1.23 X 10-7 sec-1
Based upon the data, hydrolysis will not be a
primary removal process for bupropion hydrochloride. Detailed information on this test and the methods used are
provided in Attachment II – Tier 0 – Physical Chemical Data report and
Attachment VII – References. (NOT PROVIDED THROUGH FOI ACT)
Dissociation Constant: The pK(unreadable) of bupropion hydrochloride has been determined as 8.35 (±0.02) at
25°C. Detailed information on this test
and the methods used are provided in Attachment II – Tier 0 – Physical Chemical
Data Report and Attachment VII – References. (NOT PROVIDED THROUGH FOI
ACT)
n-Octanol/Water Partition Coefficient: The log Kow
value is less than 2, therefore bupropion hydrochloride is not expected to
significantly bioconcentrate or sorb onto organic particles.
|
System |
Kow |
log KOW |
|
n-Octanol/Distilled
water |
0.048 |
-1.32 |
|
n-Octonal/Distilled
water (pH 1.2) |
0.250 |
-0.60 |
|
n-Octanol/Distilled
water (ph 6.0) |
8.10 |
0.91 |
|
n-Octanol/Distilled
water (ph 7.4) |
34.80 |
1.54 |
Detailed information on this test is provided in
Attachment II – Tier 0 – Physical Chemical Data Report. (NOT PROVIDED
THROUGH FOI ACT)
Vapor Pressure Estimate:
Estimation -2
X 10-7
Measured 3.4
(±1.17)X10-7
Bupropion hydrochloride has a relatively low vapor
pressure. Detailed information on this
test is provided in Attachment II – Tier 0 – Physical Chemical Report. (NOT
PROVIDED THROUGH FOI ACT)
UV Spectra: The
spectrum of bupropion hydrochloride shows shifts in the maxima in various solvents. Detailed information on this test is provided
in Attachment II – Tier 0) – Physical Chemical Data Report. (NOT PROVIDED
THROUGH FOI ACT)
Back a Page
Next Page
Back to Wellbutrin SR® NDA Index Page
Back to Main
Index