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.0.5
(RB 1-Apr-
Analysis
Esmolol dimer
d
. 6.5 2013)
Sample: Sample solution
Calculate the percentage of each individual impurity in
the portion of Esmolol Hydrochloride taken: Any other individual
.1.0
(RB 1-Apr-
Total impurities
e
. 2013)
rU = peak response of each individual impurity
from the Sample solution
a
.3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}propanoic acid.
rT = sum of all the peak responses from the Sample
.
b
.3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}-N-isopropyl-
solution
propionamide.
(RB 1-Apr-2013)
Acceptance criteria: See Table 2.
c
.Methyl 3-{4-[3-(ethylamino)-2-hydroxypropoxy]phenyl}propionate.
d
.Methyl 3-{4-[2-hydroxy-3-(3-{4-[2-hydroxy-3-(isopropylamino)pro-
Table 2
poxy]phenyl}-N-isopropylpropanamido)propoxy]phenyl}propanoate.
e
.Disregard any peak below 0.05%.
Relative Acceptance
Retention Criteria,
SPECIFIC TESTS
Name Time NMT (%)
PH 791: 3.05.0
.0.4
(RB 1-Apr-
WATER DETERMINATION, Method Ia 921: NMT 1.0%
Esmolol free acid
a
. 0.43 2013)
ADDITIONAL REQUIREMENTS
.Esmolol isopropylamide analog
b
.
.0.65
(RB 1-
.0.25
(RB 01-
PACKAGING AND STORAGE: Protect from freezing, and (if present)
(RB 1-Apr-
(RB 1-Apr-
USP Esmolol Hydrochloride RS
.0.84
(RB 1-
()-.
N-Ethyl esmolol
c
. (if present) Apr-2013) 0.15
C16H25NO4 HCl 331.83
a
.3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}propanoic acid.
.
b
.3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}-N-isopropyl-
propionamide.
(RB 1-Apr-2013)
c
.Methyl 3-{4-[3-(ethylamino)-2-hydroxypropoxy]phenyl}propionate.
d
.Methyl 3-{4-[2-hydroxy-3-(3-{4-[2-hydroxy-3-(isopropylamino)pro-
poxy]phenyl}-N-isopropylpropanamido)propoxy]phenyl}propanoate.
e
.Disregard any peak below 0.05%.
2013 The United States Pharmacopeial Convention All Rights Reserved.