Cleaning validation 2: Development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent
| Autor: | Wilfredo Resto, Darimar Hernández, Héctor Colón, Rosamil Rey, José Zayas |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Correlation coefficient
Detergents Clinical Biochemistry Ion chromatography Pharmaceutical Science Sensitivity and Specificity Diluent Analytical Chemistry Drug Discovery Calibration Technology Pharmaceutical Decontamination Edetic Acid Spectroscopy Chelating Agents Response factor Detection limit Gossypium Chromatography Chemistry Reproducibility of Results Fenitrothion Repeatability Reference Standards Chromatography Ion Exchange Stainless Steel Cleaning validation Diazinon Linear Models Equipment Contamination |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 44:265-269 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2007.01.037 |
| Popis: | A cleaning validation method, ion chromatographic method with conductivity detection was developed and validated for the determination of traces of a clean-in-place (CIP) detergent. It was shown to be linear with a squared correlation coefficient (r(2)) of 0.9999 and average recoveries of 71.4% (area response factor) from stainless steel surfaces and 101% from cotton. The repeatability was found to be 2.17% and an intermediate precision of 1.88% across the range. The method was also shown to be sensitive with a detection limit (DL) of 0.13 ppm and a quantitation limit (QL) of 0.39 ppm for EDTA, which translates to less than 1 microL of CIP diluted in 100mL of diluent in both cases. The EDTA signal was well resolved from typical ions encountered in water samples or any other interference presented from swabs and surfaces. The method could be applied to cleaning validation samples. The validated method could be included as a suitable one for rapid and reliable cleaning validation program. |
| Databáze: | OpenAIRE |
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