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TOPICS : 04- EUROPEAN PHARMACOPOEIA & INTERNATIONAL HARMONISATION / 01- General Chapters and Monographs  / 06- IMPURITIES CHROMATOGRAPHY 

• 01. Can you provide relative retentions for ‘Other detectable impurities’ cited in the Impurities section of a monograph?

• 02. Can the EDQM provide typical chromatograms for tests described in the monographs?

• 03. I have observed a slight difference in retention times/retardation factors compared with the monograph. What deviation is considered acceptable?

• 04. What is the limit for specified/unspecified/unknown impurities?

• 05. How to determine the total impurities? Which peaks can be disregarded?

• 06. The limit for unspecified impurities in the monograph is higher than the values defined in general monograph 2034, Substances for pharmaceutical use (Table 2034.-1) and general chapter 5.10, Control of impurities in substances for pharmaceutical use.

• 07. How are limits for impurities defined in monographs?

• 08. I observe baseline separation when the monograph describes a peak-to-valley ratio.

• 09. I cannot achieve the system suitability or signal-to-noise criteria with the described chromatographic method. Can I make any adjustments?

• 10. The monograph does not specify a correction factor for a specified impurity.

• 11. The monograph does not include chemical reference substances or relative retentions for specified impurities.

• 12. What is the difference between a peak area comparison and a quantitative limit for related substances?


 
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