The Nutraceutical sector is increasingly mature and the Quality Control of the ingredients is more demanding. For this reason, the sector should think about the use of the Primary Reference Standards for the quantification of actives in botanical extracts.
In many cases, the Reference Standards only indicate chromatographic purity (HPLC or CG) and do not certify the chromatographic assay of the product. Many companies use wrongly those Reference Standards as Primary Reference Standards and the actives quantification is affected.
Monteloeder is very aware of this issue and only uses Primary Reference Standards and, when the market can not supply them, it manufactures this type of substances internally in its own laboratory and standardizes them attaching all the analytical and characterization documentation. For this reason, companies like USP contact us to collaborate in its Reference Standards Catalog.
Francisco Cremades
Technical Director and Quality Control Manager
R&D, Process Development and Scale-up
