Toxic metal determination in Smilax calophylla preparations in Malaysia

Abstract

The DCA (Drug Control Authority), Malaysia has implemented the phase 3 registration of traditional medicines on 1 January 1992 in all pharmaceutical dosage forms of traditional medicine preparations. A total of 100 products of a herbal preparation, containing Smilax calophylla were analyzed for mercury content using cold vapor atomic absorption spectrophotometer. Results showed that 15% of the above products possessed 0.62–2.32 ppm of mercury, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. Out of these 15 products, six products with 0.62–2.32 ppm of mercury were in fact have already registered with the DCA Malaysia. The quality requirement for traditional medicines in Malaysia is not exceeding 0.5 ppm for mercury. Although this study showed that only 85% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to mercury, however, they cannot be assumed safe from mercury contamination because of batch‐to‐batch inconsistency.