Latest updates on the European and US Pharmacopoeias

Pharma & Personal Care NewsNewslistLatest updates on the European and US Pharmacopoeias

15 / 09 / 2016



As part of its Full Service Solution, Tereos continually monitors the latest updates on the European and American pharmacopoeias in regard to Tereos’ product ranges. A key step forward has recently been realized to enable pharmacopoeia harmonisation between strategic geographical areas such as the USA and Europe. On 1 December 2016, the revised USP monograph for Dextrose will be officially implemented in the USP39-NF34 2nd supplement. As the European Pharmacopeia has already offered the revised version since 1 January 2016, the parameters of European and American monographs will be almost the same.

Glucose monohydrate is in the process of achieving international harmonisation between the European Pharmacopoeia, the USP and the Japanese Pharmacopoeia.

- In the USA: With effect from 1 December 2016, Tereos’ range of Glucose monohydrate, Meritose® 200 Pharma (excipient grade), Meridex® (API grade) and Meridex® PF (injectable API grade) will comply with the revised and harmonised monograph endorsed by US pharmacopoeia.
- In the EU: Since 1 January 2016, Tereos’ range of Glucose monohydrate has complied with the revised and harmonised European Pharmacopoeia.

With the official implementation of both revised and harmonised monographs, product testing will be facilitated by avoiding the duplication of work. Most product specifications and analytical methods are aligned between EU and US pharmacopoeias. Almost 90% of attributes are harmonised, including those newly introduced with this updated version (i.e. conductivity, the liquid chromatography method for related substances and assay, etc.).
Only non-harmonised attributes and local requirements will remain country specific:

- Non-harmonised attributes are Characters/Heavy metals/Packaging and Storage/Labelling
- Local requirements are:

  • Ph. Eur.: First identification A - Specific optical rotation/Second identifications C and D/Pyrogens
  • USP: Identification A - Infrared absorption

 

What are the main changes that will be introduced with the new 9th Edition of the European Pharmacopoeia which is to be made official on 1 January 2017?

The 9th Edition of the European Pharmacopoeia will come into force on 1 January 2017 with the 9.0. As a first step of EDQM strategy of the implementation of ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) will be deleted from the individual monograph on substances for pharmaceutical use, which include the following Tereos products:
- Glucose liquid (1330) (Mylose® Pharma and Glucomalt® Pharma ranges)
- Glucose liquid spray dried (1525) (Glucodry® Pharma range)
- Maltodextrin (1542) (Maldex® Pharma range)

For information, the current and future edition dates of EU and US pharmacopoeias are as follows:


European Pharmacopoeia
US Pharmacopoeia
Current Edition 8.8 USP30-34 1st supplement
Implementation 1 July 2016 1 August 2016
Next Edition 9.0 USP39-34 2nd supplement
Publication date 1 July 2016 1 June 2016
Implementation date 1 January 2017 1 December 2016

 

 



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