Preparation of National CRMs of Active Compounds from Natural Products

According to the standard ofGB/T1500.3-2008 and the guidelines of ISO/REMCO,the preparation of National Certified ReferenceMaterials (CRMs) of active compounds was composedof the following two aspects: preparation andcertification.This paper presents an example of thepreparation of biochanin A to illustrate the preparationof National CRMs of active compounds fromnatural products.Firstly, the target compound wasextracted and purified from crude materials.Then,its chemical structure was identified by UV spectrum,IR spectrum, ESI-MS, and NMR.The purity ofthe compound was determined by HPLC with thearea normalization method.The certified value assessedby comparing the purity values from six independentqualified laboratories and the value ofuncertainty were given.Thermal analysis, residualsolvent, homogeneity testing and stability testingwas tested in the process.