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Datasheet Ractopamine-D 5 Reference number : EU/CRL: 61 Date of preparation : 1999.06.07 date 17 January, 2003 source : Rephartox Maarssen “Bank of Reference Standards”

Transcript of Reference number : EU/CRL: 61 Date of preparation : … · 1 200 220 240 260 280 300 320 340 360...

Page 1: Reference number : EU/CRL: 61 Date of preparation : … · 1 200 220 240 260 280 300 320 340 360 380 400 ... Temp. t = 0 months Homogeneity (n = 10) µg ... Cec-61a.doc Author:

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”

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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

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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

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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

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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

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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)

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datasheet EU/CRL reference standard material ractopamine-D5, page 6 of 5