Phytex was recently approached by a customer with a request to remove Pyrrolizidine Alkaloids (PAs) impurities from its raw herbal material. Earlier attempts by the customer were unable to achieve the extremely low PAs limits required, without reducing the overall yield.
Tribulus terrestris
Recent EU regulatory changes adopting a new chapter, Contaminant pyrrolizidine alkaloids (Ph. Eur. 2.8.26), require manufacturers of herbal medicinal products and foods to remove all traces of PAs from its herbal ingredients¹. PAs have been found to cause a toxic reaction in humans, when ingested with foods or herbal medicines. A similar regulation has also been established by the US FDA (USP<1567>).
The Phytex R&D team investigated various methods of purification to achieve the desired results. Eventually the team were able to successfully remove the PAs content whilst meeting overall yield requirements. Phytex were then able to scale up the process from gram quantities to commercial process batches (+100kg), scaling equipment under GMP guidelines and validating the commercial process.
The PAs content was reduced from 680,000 mg/kg to <1000 (mg/kg) with an 85-90% yield using Phytex validated process methods under cGMP conditions.
The customer was extremely satisfied with the result and has since entered into commercial relationships for ongoing purification services in 2023 and beyond.
“We are delighted we were able to achieve this result for our customer. This type of purification work is vital for many industries, especially herbal supplements, that now need to meet strict safety limits for certain impurities found widely in the herbal extract and supplements space. The Phytex team have the in-house technology, experience and facilities to achieve these outcomes under cGMP conditions.” said Stuart Smith, Managing Director of Phytex.
References:
1. European Commission Regulation 2020/2040. Maximum levels of pyrrolizidine alkaloids in certain foodstuffs. 11 December 2020.