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Answer:

When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content assigned a CRS is given in the leaflet available in the Ph. Eur. reference standards database.

For impurity CRSs used for quantification in the related substances test of the corresponding Ph. Eur. monograph, the content can be assumed to be 100%, unless otherwise indicated in the leaflet.

In all other cases, no value is assigned and no assumption can be made on the purity or content of the CRS.





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