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Chromatracer Al
 
Aluminum Determination System for Quality Control in the Pharmaceutical Industry
1. A general-purpose HPLC system with fluorescent detector is required.
No other special equipments are necessary.

 
2. Sensitive and selective aluminum determination is attainable.

 
3. Aluminum concentration in large volume parenteral (LVP) and small volume parenteral (SVP) used for total parenteral nutrition (TPN) is determined at ug/L level.

 
4. Reaction mixture is prepared by simply mixing reagents with the test sample. Chelating reaction runs at room temperature.

 
5. Since an HPLC system is used, continuous operation over 24-hour is plausible.

 
6. All raw materials and parts used for this system are strictly controlled to prevent contamination with aluminum by established purification methods.
 
A general-purpose HPLC system is used for this method. Aluminum contained in the sample is labeled with 8-quinolinol, and the resulting 1:3 complex is isolated by chromatography. Aluminum concentration is determined by the fluorescent method.

 
8-Quinolinol is the most classical and well-known chelating agent for the determination of aluminum. However if samples contain other elements, 8-quinolnol form complexes not only with aluminum but also with other metallic ions. In an analysis of aluminum in LVPs and SVPs composed of complex matrices, sensitivity sufficient to determine trace aluminum (ug/L) can not be achieved in a conventional 8-quinolinol method.

 
Key characteristic of "Chromatracer Al" lies in the kinetic differentiation mode, where no 8-quinolinol is added to the eluent. The kinetic differentiation mode HPLC using 8-quinolinol detects kinetically-inactive aluminum and cobalt complexes; other complexes quickly decompose in the column and hence, are not detected. "Chromatracer Al" uses fluorescent detector selectively to detect only the aluminum complex. Furthermore, surfactant in the reagent reduces interaction between hydrophobic substance, such as protein in a sample, and the hydrophobic stationary phase. Through the effect of surfactants, aluminum complex is selectively separated from matrices and greater accuracy is achieved.

 
Items Settings
  Flow rate 1.0 mL/min. (Note: different from 0.5 mL/min. for whole line cleaning)
  Injection volume (20-) 200 uL
  Column temperature 25C
  Wavelength (fluorescent detector) Ex = 370 nm, Em = 504 nm
  Retention time/test 3-5 min.
 
 

 
Chromatracer A1 Al-free 0.5 mL Sample vial may be used depending on the type of sample rack of HPLC. If 0.5 mL vials are used, transfer the reaction mixture to Al-free 0.5 mL Sample vials before injection into HPLC system.

 

 

1) Federal Register, 63, 176-185 (1998).
2) Federal Register, 65, 4103-4111 (2000).
3) Federal Register, 66, 7864-7865 (2001).
4) Federal Register, 67, 70691-70692 (2002).
5) Hitoshi Hoshino, Kouji Nakano and Takao Yotsuyanagi, Analyst, 115, 133-137 (1990)
6) Makoto Sato, Hajime Yoshimura, Tetsuo Shimmura, Hideki Obi, Shin-ichi Hatakeyama, Emiko Kaneko, Hitoshi Hoshino, Takao Yotsuyanagi, J. Chromatogr. A, 789, 361-367 (1997).
7) Makoto Sato, Jun Matsuda, Harunobu Murayama, Ryong-woon Shin, Emiko Kaneko and Takao Yotsuyanagi, Bunseki Kagaku, 49, 429-435 (2000).
8) Makoto Sato, Hiroki Hashimoto, Tomoyuki Ishikawa, Jun Matsuda, Hajime Yoshimura, Akio Hashimoto and Takao Yotsuyanagi, Bunseki Kagaku, 51, 507-514 (2002).
9) Junko Chiba, Masako Kusumoto, Shinichi Shirai, Kyoko Ikawa and Seizaburo Sakamoto, Tohoku J. Exp. Med., 196, 139-149 (2002).
10) Koji Kashimura, Yasuhiro Mizushima, Eiichi Hoshino, Shuzo Matsubara, J. Chromatogr. B, 791, 13-19 (2003).
11) Norikazu Nagae and Makoto Sato, American Laboratory June (2005).
 

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