Title: IMPURITIES AND CHROMATOGRAPHY  
Author: ZHATKIN Yurii Jul 09, 2019
Last Changed by: ZHATKIN Yurii Jul 15, 2019
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    Page: General Chapters and Monographs
Children (13)
    Page: Can you provide relative retentions for ‘Other detectable impurities’ cited in the ‘Impurities’ section of a monograph?
    Page: Can the EDQM provide typical chromatograms for tests described in the monographs?
    Page: I have observed a slight difference in retention times/retardation factors compared with the monograph. What deviation is considered acceptable?
    Page: What is the limit for specified/unspecified/unknown impurities?
    Page: How can I determine the total impurities? Which peaks can be disregarded?
    Page: The limit for unspecified impurities in the monograph is higher than the values defined in general monograph Substances for pharmaceutical use (2034) (Table 2034.-1) and general chapter 5.10. Control of impurities in substances for pharmaceutical use.
    Page: How are limits for impurities defined in monographs?
    Page: I observe baseline separation when the monograph describes a peak-to-valley ratio.
    Page: I cannot achieve the system suitability or signal-to-noise criteria with the described chromatographic method. Can I make any adjustments?
    Page: The monograph does not specify a correction factor for a specified impurity.
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Time Editor  
Jul 15, 2019 16:10 ZHATKIN Yurii View Changes
Jul 09, 2019 14:39 ZHATKIN Yurii