Quay Pharma is using a Waters UPLC system to provide vital analysis for herbal supplements
As a result of the success of its first project, the company has invested in a further two systems.
Product adulteration, counterfeiting and product consistency are some of the major quality control challenges for herbal products.
Equally important, the EU Directive 2004/24/EC, which came into force in the UK from April 2011, requires all herbal products sold in the country to be characterised and registered.
Quay Pharma is able to check the presence of claimed ingredients, identify unnamed substances in the formula and assess whether batches of product contain the same ingredients and quantities.
The system has already proved successful in identifying adulterants and inconsistencies in a popular herbal medicinal product manufactured in Malaysia.
The UK supplier wanted to develop an identical formula for manufacture in this country and asked Quay to assess the product and identify the 13 herbs that it claimed to contain.
The supplier was then also informed by the UK regulator (MHRA) that chlorpheniramine, a prescription-only antihistamine, had been found in the product, although the Malaysian manufacturer claimed that the MHRA was confusing this with phytochemical corydaline.
Quay was able to confirm that the capsules did contain chlorpheniramine and not corydaline. Batches of the product were then tested by UPLC-Qtof-MS to detect other adulterants, examine batch consistency and identify any unnamed substances.
The results showed that only two out of the 13 herbs required for the formulation were present and that the product contained no less than five adulterants at high levels. In addition, an undeclared herb, Gancao, was identified as providing the major herbal content.
“Effective use of relevant analytical tools is crucial to ensure the quality and accurate ingredient description of herbal supplements,” comments Professor Larry Gifford, Quay’s Chief Scientific Officer.
“There is increasing regulation of herbal medicines and this means that suppliers need to be checked carefully and their products analysed in depth to ensure they are genuine. By investing in the best analytical equipment, we can offer a fast, comprehensive and accurate service to find out if these supplements live up to their claims.”