“Recent events have many companies reexamining their herbal testing programs, and are looking for ways to make them unimpeachable,” said Elan Sudberg, CEO of Alkemist Labs. “The availability of Extrasynthese‘s high quality phytochemical standards to test against will help the industry raise the quality bar.”
Alkemist stressed that it is of tremendous importance to be able to measure the presence or content of active herbal substances in products in order to assess safety, quality and potency. Currently a big concern in the industry is assessing the herbal products supply chain “traceability” and to detect adulteration. To address these concerns, analytical methods have been developed using phytochemical standards to assist in the Quality Process.
Phytochemical standards are pure substances existing in and mostly derived from plants for which chemical structure has been determined and for which purity has been accurately measured, according to the company. They can be made by extraction and/or chemical synthesis. As they can be complex and fragile materials, their production needs advanced skills in extraction, organic chemistry and purification techniques, the main set of purification techniques being “preparative chromatography.”
After isolation, Alkemist explained that these purified substances need to be accurately qualified in order to be used as “standards,” using specific analytical techniques to determine their absolute purity and the content of ‘by-products’ like water or solvents. Good science and rigor in analysis are mandatory at this step.
“Unlike other industries such as petrochemical or metallurgy, the production of standards for herbal products is not yet seriously regulated or normalized,” said René de Vaumas, CEO of Extrasynthese. “In pharma, FDA and EMEA have started to issue guidelines and have developed a collection of ‘official standards,’ but for the herbal products industry the use of standards is voluntary, and shows a company is serious about testing their products.”
“There are very few true and trusted makers of phytochemical standards in the world, and Extrasynthese is one of them,” said Mr. Sudberg. “We are pleased to be partnering with this company because of their long history of quality and consistency of their offerings, which is a critical asset in this business.”