!"#$!"#$%!"#$ Application Note. Pharmaceutical. Udo Huber. ChemStore C/S! ChemStation Plus!"#$ LC LC/MSD CE GC A/D!"#$%&'()*+,!"#$%!"#$!

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1 !"#$!"#$%!"#$ Application Note Pharmaceutical Udo Huber ChemStore C/S! ChemStation Plus!"#$ LCLC/MSDCEGC A/D!"#$%&'()*+,!"#$%!"#$!"#$% ChemStation Plus!"#$%!"#$%&'()*+,-!"#$%&!"#$%&'()!"#$%

2 ChemStation Plus!"#$!QC!"#$%&'!"!"#$%&!"#!"#$%&'QC!!"#!" 1!"#$%&!"#$%&'() QC!"#$%&!"#!"#$!"#$%&!"#$%&!!"#$%&'()*+,!"#$!"#$ ChemStation Plus 123 Agilent 1100 HPLC!!!"#$%&'(!"#$%&'()*+,!"#$ QC!"#$ %&'!"#$%&'()*+!"!#$%&'()*+!"#$%&'()!!"#$%&'(! ChemStation Plus!"#$%&'()QC!"#$%!"!"#$%&!"#!"#!$%&'(!"!"#$%&'!"#$%&'()*$!"#$!"#$%&'()*!"#$%&'!"ChemStation Plus!"#$%&'()*+!!"#$%&'!"#$%study!"#$%&'()!"#$%&'()!"#$%&'()*+!Agilent 1100!"# Agilent 1100!"#$% Agilent 1100!"#$%& 1100!"#$%&'!" ChemStation A.06.04!"! ChemStation Plus!" B.01.01!"#$!!"#$%&'(!"#$%&'(!"#$%&' Zorbax SB-C mm, 3.5 µm A=0.025M KH 2 PO 4! ph=3! B= 0 10 % B % B % B 1 ml/! 11! µl UV!"#$%204 nm!"!"#$%&'(

3 !"!!"#$%&'(sulfamethoxazole trimethoprim!5!"#$%! ChemStation Plus Agilent 1100 HPLC! QC! ChemStation Plus!!"#$ 5!!"#$%&'()*+,!"#$%&'!!"#$%&'()!*+ ChemStation Plus!"#!"#$%&!"#$!%&'(!"#$%&'(!"#!"#$% QC!"#!"#$%!!"#$%&'()!"#$%&'!"!"#$%&'!"!"#!"#$%&!"#$%&'()*+,!"#$%&'!"#$% QC!"#!"#$%&'()*+,!"#$!"#$%!"#$%&'!"!"#$%&'!"!"#$%&'(!"#$!"#$%!"#$%&'()*+,!"#$%&'(!"#!"#$%&!"#$%&!"#!"#$%&'!"#$!"#$%!"#$%&'()*!"#$%&'()*!"#$!"#$%&'()*+!"#$!"#$%&'(!"#$%&'()*!"#$%&'()*+!"!"#$!"#$%&'()*+!"#$%&! purge!"#

4 !"#$ QC!"#$%&'!"#$%&'()*+!"#$%&'()* ChemStation Plus!"!"#! 2!"#!!"#$%!!"#!!!"#$!"#$%!"# $%&'()* 1a1b!"#$%&'()*+ Amount [mg/l] QC Chart of Sulfamethoxazole Amount / [Sulfamethoxazole] Upper critical line (Amount[ Sulfamethoxazole ]) Upper warning line (Amount[ Sulfamethoxazole ]) Lower warning line (Amount[ Sulfamethoxazole ]) Lower critical line (Amount[ Sulfamethoxazole ]) May 21 May 23 May 25 May 27 May 29 May 31 Jun 02 Jun 04 1a 5 sulfamethoxazole!"#$%&!"#$y!!!"#$%&'()*+!"#$qc!!"#$% 5 25 trimethoprim!"#$ 45mg/l!X!"!"#$% field! /!"#$!"#$!" Amount [mg/l] QC Chart of Trimethoprim Amount / [Trimethoprim] Upper critical line (Amount[ Trimethoprim ]) Upper warning line (Amount[ Trimethoprim ]) Lower warning line (Amount[ Trimethoprim ]) Lower critical line (Amount[ Trimethoprim ]) 10 May 21 May 23 May 25 May 27 May 29 May 31 Jun 02 Jun 04 1b 5 trimethoprim!"#$%&

5 !"#$%&!"#! 2 2a 2b!"#!"#$%&!"#$%&'!"!!"#!$%&' +2δ2!"#$%&'!" #+3δ!"# QC!"# Amount [mg/l] Control Samples (Sulfamethoxazole) Amount / [Sulfamethoxazole] Upper critical line (Amount[ Sulfamethoxazole ]) Upper warning line (Amount[ Sulfamethoxazole ]) Center line (Amount[ Sulfamethoxazole ]) Lower warning line (Amount[ Sulfamethoxazole ]) Lower critical line (Amount[ Sulfamethoxazole ]) May 21 May 23 May 25 May 27 May 29 May 31 Jun 02 Jun 04 2a sulfamethoxazole!"#$ Amount [mg/l] 100 Control Samples (Trimethoprim) Amount / [Trimethoprim] Upper critical line (Amount[ Trimethoprim ]) Upper warning line (Amount[ Trimethoprim ]) Center line (Amount[ Trimethoprim ]) Lower warning line (Amount[ Trimethoprim ]) Lower critical line (Amount[ Trimethoprim ]) May 21 May 23 May 25 May 27 May 29 May 31 Jun 02 Jun 04 2b trimethoprim!"#$

6 !!"#$%&'()!"#$%&'() Peak Symmetry for Sulfamethoxazole Symmetry / [Sulfamethoxazole] Upper critical line (Symmetry[ Sulfamethoxazole ]) Upper warning line (Symmetry[ Sulfamethoxazole ]) Lower warning line (Symmetry[ Sulfamethoxazole ]) Lower critical line (Symmetry[ Sulfamethoxazole ])!"! 0.8!"#$%&1!"#$%&1!"!"#$1!"#$!"#$%&'(3A3B!"#$%&'( 0.7 3a sulfamethoxazole!" 3a Sulfamthoxazole!"# 0.75!"#!"#$%&'()*+,- Trimethoprim!"#$ 3B!" 1.05!"#!"!"#$%&' 1.15!"!"#$!"#$%#&' Peak Symmetry for Trimethoprim Symmetry / [Trimethoprim] Upper critical line (Symmetry[ Trimethoprim ]) Upper warning line (Symmetry[ Trimethoprim ]) Lower warning line (Symmetry[ Trimethoprim ]) Lower critical line (Symmetry[ Trimethoprim ]) b trimethoprim!"

7 !"#$%&'()*+,!" USP!"#$% 4a 4b!"#$%& 1.6 Tailing Factor for Sulfamethoxazole Tail Factor / [Sulfamethoxazole] Upper critical line (Tail Factor[ Sulfamethoxazole ]) Upper warning line (Tail Factor[ Sulfamethoxazole ]) sulfamethoxazole trimethoprim!"#$ !"#$%&!"#!"#$1!"#$!" QC!"# a sulfamethoxazole!"# Tailing Factor for Trimethoprim Tail Factor / [Trimethoprim] Upper critical line (Tail Factor[ Trimethoprim ]) Upper warning line (Tail Factor[ Trimethoprim ]) b trimethoprim!"#

8 !"#$%&'()* 5 sulfamethoxazole!"#$%&'(!!"#$%&'()6 sulfamethoxazole!" Sulfamethoxazole!"#$ 1.9!"#$%&'() !"#!"#$ Resolution (hw) for Sulfamethoxazole Resol (hw) / [Sulfamethoxazole] Upper critical line (Resol (hw)[ Sulfamethoxazole ]) Upper warning line ((Resol (hw)[ Sulfamethoxazole ]) Lower warning line (Resol (hw)[ Sulfamethoxazole ]) Lower critical line (Resol (hw)[ Sulfamethoxazole ]) sulfamethoxazole!" 2.0 Selectivity for Sulfamethoxazole Selectivity / [Sulfamethoxazole] Lower warning line (Selectivity[ Sulfamethoxazole ]) Lower critical line (Selectivity[ Sulfamethoxazole ]) sulfamethoxazole!"

9 !!"#$%&'()!"#$%&'()!"#$%&'()*+,!"#$%&!"#!!!!"# Pressure (bar) Pump Pressure Start Pump Press /!"#$%&'()*+,- 60!"#$%&'()*+!"#$%&!"#!"#$%&'()*+! 7!!"#$%&'()*!!"#$%&'()*+!8Agilent 1100!"#$%&'(!) Pump Flow (ml/min) 1.1 Pump Flow Start Pump Flow / !

10 !"#$%&'()*+, Temperature Start Left Temp /!"#$%&'()!"#$%&!"#! Agilent 1100!"#$%&'()!"#$%&'()*+,!"#!" !"#

11 Agilent 1100 ChemStation Plus!"# QC!"!"#$%!"#$!"#$%&'()*+,-!"#$%&'()*+,!"#$%!"#$!"#$%!&!" ChemStation Plus!"!!"#$%&'()*+,!"#$!"#$%!"#$!"#$% Microsoft Windows!"!"#$%&!"!"#!"#!!"#$% 1 Drive down costs and raise productivity Agilent Technologies Brochure Brief, 1999, publication number E 2 Agilent ChemStation Plus Agilent Technologies Specifications, 1999, publication number E 3 From data to decisions Agilent Technologies CD-ROM, 1998, publication number E

12 Udo Huber is an Application Chemist based at Agilent Technologies, Waldbronn Germany.!"#$%&'()*!"#$%&!"#$%&'()*+, -!"#$!"#$%&'()*+,-!"#$%2004! CHCN

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