Analysis of lead in tongkat Ali hitam herbal preparations in Malaysia

Abstract

The DCA (Drug Control Authority), Ministry of Health, Malaysia implemented the phase three registration of traditional medicines on January 1st, 1992. As such, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation obtained in Malaysia, containing tongkat Ali hitam, either single or combined preparations, were analyzed for the contamination of a heavy toxic metal, lead, using atomic absorption spectrophotometer, after performing a simple random sampling to enable each sample an equal chance of being selected in an unbiased manner. Results showed that 17% of these products contained 10.3–20.3 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. The quality requirement for traditional medicines in Malaysia is not exceeding 10 ppm for lead. Out of these 17 products, 7 products have been registered with the DCA, Malaysia whilst the rest, however, have not registered with the DCA, Malaysia. Although this study showed that 83% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, however, they cannot be assumed safe from lead contamination because of the risk of batch-to-batch variability.

Keywords:

• Atomic absorption spectrophotometer
• drug control authority Malaysia
• herbal preparations
• lead analysis
• Polyalthia bullata
• quality requirements for traditional medicines

Acknowledgement

This work was supported by the research grant of University Science Malaysia (304/Pfarmasi/633118).