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Update on the review of the CEP application regarding an impurity in the active substance paracetamol

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Certification of suitability (CEP)
News
03 September 2020
Strasbourg, France

The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).

PCA is a known impurity which may be formed under certain conditions during the manufacturing process of paracetamol, and which should be removed or limited by a suitable control strategy. The levels of PCA reported by the media are well below the Acceptable Intake (AI) of 34 μg/day defined in the addendum of the guideline ICH M7 (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk), even when using a high daily dose of paracetamol. In addition, no information is available about the analytical methods used to test the batches nor their validation.

Since the safety of paracetamol is not compromised, as the reported results did not show 4-chloroaniline to be above the internationally agreed acceptable limit, no action has been taken on the concerned certificate, which hence remains valid.

Update:

On August 27 2020, the MEB and the Health and Youth Care Inspectorate (IGJ) published an investigation report on the safety of paracetamol and how safety is ensured. The report (in Dutch and English) can be found here: "Report on paracetamol and PCA". A translated summary in English is also available: "Summary - Report on paracetamol and PCA".

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