EP UPDATE: Pharmacopoeial & Regulatory Review 11 Dec 2018

EP UPDATE: Pharmacopoeial & Regulatory Review, Dec 2017

Current Edition: EP, Version 9, Supplement 9.2

Under Review: Edition Supplement 9.4, Issue Date: 01 April 2018

2.2.32 Loss on Drying:

Amendment of standard used for instrument qualification for drying in an oven at a specified temperature.

2.5.12 & 2.5.32 Water Semi-Micro & Micro Determination

Amendment of standard used for instrument qualification.

Purified Water Monograph:

• Removal of requirement to perform Heavy Metals testing and replaced with the following requirement:

  “If PW in bulk does not meet the requirement for conductivity prescribed for WFI, a risk assessment according to general chapter 5.20 Elemental impurities is carried out. The risk assessment should consider the role of water in the manufacturing process, in particular when water is used in a process but is no longer present in the final product.”

Note: Chapter 5.20 is being introduced in supplement 9.3 (Jan 2018) and refer to ICH Q3D guidelines.

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