Science meets regulation.

Area of Science:

• Analytical Chemistry
• Pharmacognosy
• Biotechnology

Background:

• European Pharmacopoeia (Ph. Eur.) sets quality standards for medicines, including herbal drugs (HD).
• Traditional HD quality control relies on morphology, which is expert-dependent and limited for assay.
• Purity tests for heavy metals, aflatoxins, and pesticides are time-consuming and equipment-intensive.

Purpose of the Study:

• To survey alternative and complementary analytical tools for herbal drug quality control.
• To identify methods that can overcome limitations of traditional pharmacopoeial approaches.

Main Methods:

• Literature survey of scientific databases (PubMed, SciFinder, Scopus, Web of Science).
• Focus on analytical methods for identification, purity, and quantification of botanical products.

Main Results:

• DNA fingerprinting (barcoding) enables accurate species-level identification.
• Nuclear Magnetic Resonance (NMR) provides metabolite fingerprinting and quantitative analysis.
• Near Infra Red (NIR) spectroscopy offers rapid qualitative and quantitative analysis.
• Biosensors show potential for detecting specific compounds, heavy metals, mycotoxins, and pesticides.

Conclusions:

• Alternative methods offer rapid, sensitive, and selective analysis directly on complex matrices.
• These techniques can be portable and disposable, enhancing analytical capabilities.
• Advanced analytical tools promise to revolutionize herbal drug quality control.