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Introduction to traditional Chinese medicine chemical reference substance

National Drug Standards of Chinese chemical reference substance is a kind of national drug standards material shall mean containing single ingredients, mixing ingredients or combination of ingredients for medicines (including Pieces), extract, medicine and other testing and calibration of instruments there are three categories:

①Identification of traditional Chinese medicine chemical reference substance: mainly used in Chinese herbal medicine, Chinese Herbal Medicine, Herbal Extracts and proprietary thin layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC) chromatography and other identification items, content It should reach 95%;

②Determination with traditional Chinese medicine chemical reference substance: for Chinese herbal medicine, Chinese Herbal Medicine, Herbal Extracts and proprietary ultraviolet spectrophotometry (UV), thin layer chromatography scanning (TLCS), high performance liquid chromatography (HPLC), Gas chromatography (GC), liquid chromatography-mass spectrometry usage (LCMSMS), GC-MS (GCMS) and other determination items, the content should be more than 98%;

③Related substances with traditional Chinese medicine chemical reference substance: for Chinese herbal medicine, Chinese Herbal Medicine, Herbal Extracts and proprietary of TLC, HPLC, GC and other chromatography related substances, the distinction between a limited inspection of medicinal species or toxic components, etc., depending on the purpose shall comply with the identification or determination of content by reference purity requirements;


Poetry Dandenong Quality Control Introduction

Poetry Dande Chinese medicine chemical reference substance currently has 1,000 kinds of product categories, most of the species are included in the "People's Republic of China Pharmacopoeia" as the main testing indexes and quality control of Chinese herbal medicines, all products were identified by mass spectrometry (MS) and nuclear magnetic resonance resonance (NMR) confirmed the content of the product were characterized by high performance liquid chromatography (HPLC) or gas chromatography (GC) detection, poetry Dande Chinese medicine chemical reference provides product quality inspection report. 

Quality System:Poetry Dande production of traditional Chinese medicine chemical reference calibration Perform the following quality control system

①ISO Guide 34: 2009 Certified Reference Material (production) by General requirements

      ②ISO / IEC17025: 2005 testing and calibration laboratories General requirements

      ③CNAS-CL04: 2010 standard reference material producer Accreditation Standards

      ④JJF 1343-2012 Certified Reference Material (production) General requirements for bodies

Quality Inspection:By a CNAS accredited laboratory for quality testing, divided into the following three ways

      ①General - MS, NMR, 13C NMR, HPLC or gas chromatography

      ②Traceability - verification of data traceable to China Academy of traditional Chinese medicine chemical food and drug reference

      ③Value - detection principle of conservation of mass of water, organic solvents, inorganic impurities, the organic component

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