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Transcript of Reference number : EU/CRL: 61 Date of preparation : … · 1 200 220 240 260 280 300 320 340 360...
Datasheet Ractopamine-D5
Reference number : EU/CRL: 61
Date of preparation : 1999.06.07
date 17 January, 2003
source : Rephartox Maarssen
“Bank of Reference Standards”
datasheet EU/CRL reference standard material ractopamine-D5, page 1 of 5
N
H O
O HO H DD
DD
D
H
Name : N-[2’-(4-hydroxyphenyl)-2’-hydroxyethyl]-1-trideuteromethyl-2-dideutero-3-(4- hydroxyphenyl) propylamine
Synonym : Ractopamine-D5
Molecular formula : C18H18D5NO3 (.HCl)
Cas # : not available Molecular weight : 306.42 Indication of purity : > 92 % Last update : 2000.07.25 Methods used for characterization I IR spectroscopy II UV spectroscopy III Mass spectrometry IV 1H-NMR spectrometry V Homogeneity and stability obtained with GC-MS
datasheet EU/CRL reference standard material ractopamine-D5, page 2 of 5
I IR spectroscopy Instrument: Bruker IFS-55 FTIR; detector DTGS Sampling technique: DRIFT
Ractopamine-D5
0
0.005
0.01
0.015
0.02
0.025
0.03
0.035
0.04
400900140019002400290034003900
Wavenumber (cm -1)
Kub
elka
Mun
k U
nits
datasheet EU/CRL reference standard material ractopamine-D5, page 3 of 5
II UV spectroscopy
Instrument: Cary 3 UV-Visible Spectrophotometer Concentration Ractopamine-D5 10 mg/l dissolved in ethanol
Tabel 1: The UV spectrum of ractopamine-D5
Peak no. Wavelength (nm) Absorbance
1 225.0 0.48752 2 278.0 0.09878
Ractopamine-D5
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
200 220 240 260 280 300 320 340 360 380 400
Wavelength (nm)
Ab
sorb
ence
datasheet EU/CRL reference standard material ractopamine-D5, page 4 of 5
III Mass spectrometry Instrument: Hewlett Packard 5989 A MS
GC-MS spectrum, DIP = direct inlet probe
Instrument: Hewlett Packard 6890 Series MSD
GC-MS spectrum, Full Scan (EI) Mass spectrometry after TMS-derivatisation
100 120 140 160 180 200 220 240 260 280 300 320 3400
2000
4000
6000
8000
10000
12000
14000
16000
18000
m/z-->
AbundanceAverage of 6.059 to 8.013 min.: 99102604.D (-)
107
123135
153
165
183
197 212 227239 255 272 288299307 335338
datasheet EU/CRL reference standard material ractopamine-D5, page 5 of 5
IV 1H-NMR spectrometry Instrument: JEOL Delta GSX270 Solvent: D2O
V Homogeneity and stability obtained with GC-MS
Temp. t = 0 months Homogeneity (n = 10) µg (m ± RSD)/ ampoules
t = 1 month (n = 2) µg (m ± RSD)/ ampoules
4 ºC (94 ± 7) - 23 ºC (96 ± 2) 37 ºC (95 ± 1)
datasheet EU/CRL reference standard material ractopamine-D5, page 6 of 5