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New batch sometimes requires new test method

A customer used a Ph. Eur. reference standard for a test on related substances with the HPLC method described in the monograph, but could not see the impurity peak in the chromatogram when using a new batch of the impurity CRS, although he did not make any modifications. Therefore, he contacted our technical support. The solution We solved the issue as follows: In this case, the Ph. Eur. impurity reference standard was changed by the EDQM from a pure substance to a mixture where the impurity under test was spiked to the active ingredient. Consequently, the dissolution method of the CRS has been changed, which was noticed on the leaflet of the new batch. Please always keep in mind, that changes in a batch can influence the test method in the monograph. The leaflets coming with certain EPCRS inform about such latest changes on Ph. Eur. methods and procedures before these changes are published in the supplements to the current edition. Further information on leaflets can be found in General Chapter 5.12 of the Ph. Eur. where it is stated under paragraph 5 (Production, Labelling, Storage and distribution): “Leaflets. An accompanying explanatory leaflet may also be provided giving information needed for correct use of the reference standard. An explanatory leaflet is considered as part of the labelling. Where stated in a monograph, a chromatogram is included in the leaflet.” picture: iStock Photo

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