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Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent.

Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Research Abstract Details 

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  • Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Abstract Text:

    wilfredo restoWilfredo Resto,darimar Darimar ,rosamil reyRosamil Rey, , zayas Zayas,

    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.

    Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Publishing Authors By Initials

    w restoW Resto,d D ,r reyR Rey,h H ,j zayasJ Zayas,

    For similar investigative techniques: technology, pharmaceutical research abstracts see: investigative techniques: technology, pharmaceutical research

    PUBMED ID PMID:

    MEDLINE DATE:

    Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Journal Published:

    PUBLICATION TYPE: Research Support, N.I.H., Extr

    Journal: Journal of pharmaceutical and biomedical analysis

    VOLUME: 44

    Page Numbers: 265-9

    Journal Abbreviation:

    ISSN: 0731-7085

    DAY: 30

    MONTH: 01

    YEAR: 2007

    Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Information

    Number of References:

    LANGUAGE: eng

    NlmUniqueID: 8309336

    Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Keywords Mesh Terms:

    KEYWORDS: Technology, Pharmaceutical

    MESH TERMS: chemistry

    Chemical & Substance for Abstract: Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent. Information

    Substance Name: Edetic Acid

    Registry Number: 60-00-4

    Grant and Affiliation Information for Cleaning validation 2: development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent.

    AFFILIATION: Department of Chemistry, University of Puerto Rico-Cayey, Antonio R. Barceló Ave. Cayey, PR 00736, USA.

    Country: England

    England Research PublicationEngland Research Publication

    AGENCY: United States NIGMS

    GRANT: 5R25 GM59429-08

    ACRONYM: GM

    MEDLINETA: J Pharm Biomed Anal

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    ACCESSION NUMBER:

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