Revision of the USP General Notices for USP 37/NF 32

On 27 December 2013, the USP published the "General Notices" for the second supplement to USP 37-NF 32.

The last change concerns section 5.60.30 on elemental impurities. The requirements of the General Chapters <232> and <2232> will enter into force as of December 1st, 2015.

In the future, the "General Notices" will also contain a modified sections 6.80.30 on temperature reading devices.

This section states that temperature reading devices used for Pharmacopeial tests have to comply with the specifications i.e. have to be traceable to an NIST standard or equivalent ones. Classical liquid-in-glass type thermometers, analog or digital devices for the measurement of temperature (like for example resistance temperature device) belong to the measuring devices which can be used.

The table presented under section 8.2.40 entitled "Weights and Measures" is a new part of the "General Notices"; this table lists the different units including the International System of Units (SI) and the symbols used for each of them.

Section 7.20 on rounding rules has remained unchanged. What has to be rounded? When does a result conform? When not? It seems to be generally pretty unknown that those provisions about the rounding of analytical results can be found in the General Notices of each USP-NF edition.

Please see the complete USP Document General Notices and Requirements for more detailed information.

Go back

GMP Conferences by Topics