If the components to be analyzedhavenoreadily detectable physical properties such as absorbance or fluorescence, the detection is achieved by changing the components to suitable derivatives.〔【出典】第十六改正日本薬局方(平成23年3月24日 厚生労働省告示第65号)〕
When an analytical procedure reveals the presence of other peaks in addition to those of the degradation products (e.g., the drug substance, impurities arising from the synthesis of the drug substance, excipients and impurities arising from the excipients), these peaks should be labeled in the chromatograms and their origin(s) discussed in the validation documentation.〔【出典】ICHガイドライン 〕
Where the analysis has been carried out by a repacker or reprocessor, the Certificate of Analysis should show the name, address and telephone number of the repacker/reprocessor and a reference to the name of the original manufacturer.〔【出典】ICHガイドライン 〕