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PhEur - Uniformity of Dosage Units Proposal

Monday the 4th April 2011

There is a proposal for a new general chapter in the European Pharmacopoeia – Demonstration of Uniformity of Dosage Units (UDU) using large sample sizes (see attached).

In order to take advantage of increased batch control offered by process analytical technology (PAT) tools, for example large sample sizes used for the control of uniformity of dosage units, a new Ph. Eur. general chapter 2.9.47 is proposed. Comments on the proposed general chapter should be submitted by 30 June 2011.

The document can be found at the following site:

Peter Gough, Partner, NSF-DBA, UK

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