Tuesday, 9 April 2019

Ph.Eur. micro determination (2.5.32.) revised


The chapter on micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8. News from EDQM.

The revised part is reproduced here after:

“The instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material. Sodium aminosalicylate dihydrate for equipment qualification CRS may be used when proceeding by direct or liquid sample introduction, whereas amoxicillin trihydrate for performance verification CRS may be used with the evaporation technique.”

The EDQM provides Sodium aminosalicylate dihydrate for equipment qualification CRS (catalogue code Y0001816) and amoxicillin trihydrate for performance verification CRS (catalogue code Y0001521), the latter should be used only for micro determination of water with oven.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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