A common question in training seminars is “How do I deal with unknown peaks in HPLC analysis?” My first answer is a facetious one: “Try TOC; there are no unknown peaks in TOC!” However, TOC is not without its problems. To directly answer the question about unknown peaks in HPLC analysis, the first attempt should be to clarify the question. By unknown peaks, we are talking about unknown peaks in the HPLC samples taken in the cleaning validation protocol itself.
The first attempt should be a preventive one. That is accomplished by trying to identify in the HPLC analytical development all possible “unknown” substances.
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Friday, October 24, 2008
Dealing with Unknown Peaks
Journal:
Cleaning Memo for FEBRUARY 2005
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