A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Quadramet Online, Description, Chemistry, Ingredients - Samarium SM 153 Lexidronam
Quadramet Online, Description, Chemistry, Ingredients - Samarium SM 153 Lexidronam
QUADRAMET®
(Samarium SM 153 Lexidronam Injection)
513145-0399 March 1999
Therapeutic –For Intravenous Administration
DESCRIPTION
Quadramet† is a therapeutic agent consisting of
radioactive samarium and a tetraphosphonate chelator, ethylenedi-aminetetramethylenephosphonic
acid (EDTMP). Quadramet is formulated as a sterile, non-pyrogenic, clear, colorless
to light amber isotonic solution of samarium-153 lexidronam for intravenous
administration. Quadramet does not contain a preservative.
Each milliliter contains 35 mg EDTMP•H2O,5.3 mg
Ca [asCa(OH)2], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP
(anhydrous calc.), 5-46m g samarium (specific
activity of approximately 1.0-11.0 mCi/m g Sm),
and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.
The ionic formula is 153Sm+3 [CH2N(CH2PO3-2)2]2,
and the ionic formula weight is 581.1 daltons (pentasodium form, 696).
The pH of the solution is 7.0 to 8.5. Quadramet is supplied
frozen in single-dose glass vials containing either 2 mL with a total activity
of 3700 MBq (100 mCi) or 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.
Physical Characteristics: Samarium-153 is produced in
high yield and purity by neutron irradiation of isotopically enriched samarium
Sm 152 oxide (152Sm2O3). It emits both medium-energy
beta particles and a gamma photon, and has a physical half-life of 46.3 hours
(1.93 days). Samarium-153 has average and maximum beta particle ranges in water
of 0.5 mm and 3.0 mm, respectively. The primary radiation emissions of samarium-153
are shown in Table 1.
|
TABLE 1 - SAMARIUM-153 PRINCIPAL RADIATION EMISSION
DATA
|
|
|
Radiation Energy (KeV)*
|
Abundance
|
|
Beta
|
640
|
30%
|
|
Beta
|
710
|
50%
|
|
Beta
|
810
|
20%
|
|
Gamma
|
103
|
29%
|
* Maximum energies are listed for the beta emissions, the average
beta particle energy is 233 keV.
External Radiation: The specific gamma-ray constant
for samarium-153 is 0.46 R/mCi-hr at 1 cm (1.24x10-5 mSv/MBq- hr
at 1 Meter). The half-value thickness of lead (Pb) for samarium-153 is approximately
0.10 mm. The use of 1 mm of lead will decrease the external radiation exposure
by a factor of approximately 1,000. Quadramet should be stored in a lead-shielded
container and frozen until use.
Radioactive decay factors to be applied to the stated value
for radioactive concentration at calibration are given in Table 2. All radioactivity
is calibrated to the reference date and time on the vial.
|
TABLE 2 - SAMARIUM-153
PHYSICA L DECAY CHART, HALF-LIFE 46.3 HOURS (1.93
DAYS)
|
|
Time (hour)*
|
Factor
|
Time (hour)*
|
Factor
|
|
-48.0
|
2.05
|
+1.0
|
0.99
|
|
-36.0
|
1.71
|
+2.0
|
0.97
|
|
-24.0
|
1.43
|
+3.0
|
0.96
|
|
-20.0
|
1.35
|
+4.0
|
0.94
|
|
-16.0
|
1.27
|
+6.0
|
0.91
|
|
-12.0
|
1.20
|
+8.0
|
0.89
|
|
-8.0
|
1.13
|
+12.0
|
0.84
|
|
-6.0
|
1.09
|
+16.0
|
0.80
|
|
-4.0
|
1.06
|
+20.0
|
0.74
|
|
-3.0
|
1.05
|
+24.0
|
0.70
|
|
-2.0
|
1.03
|
+36.0
|
0.58
|
|
-1.0
|
1.02
|
+48.0
|
0.49
|
|
*Time = hours before (-) or after (+) calibration
|
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