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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Pharmaceutical Microbiology