The Pharmaceutical Journal
Vol 273 No 7322 p597
23 October 2004

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· Concordance
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Letters to the Editor

Medicines stability

Different tests for different regions

From Dr V. L. Bull, MRPharmS

My understanding is that the International Committee on Harmonisation (ICH) guideline on stability testing of new drug substances and products (Q1A[R2]), as implied by Pamela Bradshaw and Anthony Jarvis (PJ, 9 October, p514) or directly quoted by Geoff Crumplin (ibid, p515), may have been misinterpreted. Although the stability of medicines is tested at 40±2C/75±5 per cent relative humidity (RH), these are considered to be accelerated conditions and, as such, are part of a battery of tests to establish safe, long-term storage under less aggressive conditions.

For marketing in the EU, US and Japan, long-term stability needs to be demonstrated at 25±2C/75±5 per cent RH. The guideline allows for the fact that “significant change” may be seen under accelerated conditions during the six-month test period, prescribing an alternative intermediate storage condition under which testing is to be undertaken. Thus, there is no requirement to demonstrate long-term stability for storage at 40±2C/75±5 per cent RH.

Demonstration of long-term stability at 25±2C/75±5 per cent RH is intended for products marketed in, as the guideline describes, climatic zones I and II. Medicines intended for use in climatic zones III and IV (in brief, hot and dry or hot and humid) should be tested in accordance with ICH guideline Q1F (“Stability data package for registration applications in climatic zones III and IV”). This requires demonstration of long-term stability at 30±2C/65±5 per cent RH, which I presume will not be the case for most medicinal products marketed in the UK.

Vincent Bull
Otley, West Yorkshire

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