Pharmaceutical Branch

Raw materials and herbal products testing

Pesticides

While the increase of pesticides use can help to boost production, at the same time it can lead to the accumulation of harmful chemical residues in herbal products, therefore, trace-residue testing became a necessity. In the wake of the development and expansion of the use of pest control products – the European Pharmacopoeia implemented a norm ordering manufacturers to control pesticide residues in herbal products. So as to ensure the safety of herbal medicinal products and meet standards one must have a certificate to conduct pesticide residue testing.

 

At J.S. Hamilton Laboratories – we are continuously researching innovative testing methods that improve testing efficiency in cohesion with the guidelines of European Pharmacopoeia. Therefore, we have validated three methods of estimating the pesticide residue in herbal products:

 

  • Labelling of pesticide residue in herbal products using analytical tool of Gas Chromatography coupled to Tandem Mass Spectrometry GC/MS/MS (method PES/01/2011/1);
  • Labelling method that determines the amount of inorganic bromides using gas chromatography with electron capture detector (method PES/02/2011/1);
  • Labelling of dithiocarbamate residues calculated as carbon disulphidedetermined by gas chromatography with electron capture detector (method PES/03/2011/1).

 

 

Aflatoxins

Yet another serious health hazard for consumer can be posed by contamination of herbal drugs with carcinogenic aflatoxins. Belonging to a group of mycotoxins, aflatoxins are produced by certain molds.
Most common aflatoxins which are found on food products, including herbal materials, are aflatoxins B1, B2, G1 and G2. They are carcinogenic, genotoxic and hepatotoxic. Among them aflatoxin B1 is considered the most toxic naturally occurring carcinogenic substance. Due its toxicity, manufacturers are obligated to meet restrictions of European Pharmacopoeia to analyze levels of aflatoxin B1 in herbal drugs. Monograph Ph. Eur. 01/2008:20818 gives the determination method of the aflatoxin B1 content in herbal drugs (“Determination of aflatoxin B1 in herbal drugs”).

 

In our state of the art facilities we have developed and validated following methods:

 

  • Determination method of aflatoxin B1 determination in herbal materials in cohesion pharmacopoeial requirements (AFL/55/2010/1).
  • Determination method of aflatoxin B1 and the sum of aflatoxins B1, B2, G1 and G2 in herbal materials according to pharmacopoeial requirements. Method covers the range from 1,0µg/kg to 6,0µg/kg for each of aflatoxins B1, B2, G1 and G2 (AFL/01/2012/1).