The European Pharmacopoeia zinc oxide monograph (0252) is in use and was last revised in Supplement 10.6 (Pharmeuropa 32.1). In that revision the cadmium and lead tests were kept “with the updated limits”, in line with the Ph. Eur. strategy for implementing ICH Q3D. A thallium limit of 5 ppm was added, and the arsenic test was deleted. The free pages do not give the numeric cadmium or lead limits.
Key numbers
History page, Supplement 10.6: “Cadmium, Lead: in line with the Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities, the test will be kept with the updated limits. In addition, the following impurity will be added: Thallium (5 ppm). Arsenic: … the test is deleted.” Earlier corrections are listed for Editions 7.0 and 6.0 and Supplement 5.5. Three certificates of suitability for zinc oxide are listed as valid, held by manufacturers in the Netherlands, Canada and Germany. The monograph is not interchangeable under ICH Q4B and not harmonised across pharmacopoeias.
Methods (brief)
These are database pages printed from the EDQM Knowledge Database. The monograph text itself is subscription-only and was not obtained.
Evidence fitness
The record supports the regulatory history of the pharmacopoeial grade of zinc oxide that the Canadian and European frameworks rely on. It supports thallium at 5 ppm as a current Ph. Eur. zinc oxide specification. It cannot supply the lead or cadmium limit.
Limitations
The numeric cadmium and lead limits are needed before any statement about pharmacopoeial-grade zinc oxide as a source of lead in finished creams can be made. They were not obtained.
Related evidence
- Diaper Cream, ZnO-Based
- ICH Harmonised Guideline Q3D(R2): Guideline for Elemental Impurities
- Thallium
Update history
No substantive edit history is available in this build. The full commit record is available in git.