Изменения в Европейской фармакопее

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Sergey
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Изменения в Европейской фармакопее

Сообщение Sergey » 23 май 2015 13:09

European Pharmacopeia updates
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Some updates of interest in relation to the European Pharmacopeia:

European Pharmacopoeia 8th Edition - Supplement 8.5 (implementation date 1st July 2015)

General Chapters

2.2.32 Loss on drying

Clarification of the way instrument qualification is to be performed.

2.5.12 Water: semi-micro determination

Clarification of the way instrument qualification is to be performed.

2.7.18 Assay of human coagulation factor II

EDTA has been removed from the dilution buffer because its presence has been reported to inhibit the ecarin-dependent coagulation factor II activation and cause a decrease in the sensitivity and precision of the assay.

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