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Testing and quality standard of
Published:2016-08-17 16:26:25    Text Size:【BIG】【MEDIUM】【SMALL
Chinese medicine testing services
Test sample:Original Chinese medicine herbs, Chinese Herbal Medicine, Herbal Extracts, Chinese medicine, natural plants, natural extracts, natural medicine, etc.
Testing standards:Chinese Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, international standards, national standards, industry standards, etc.
Test items:Identification of items - character identification, microscopic identification, physical and chemical identification, TLC, molecular biological identification
Checks - impurities, acid value, moisture, ash, acid insoluble ash, residue on ignition, loss on drying
Extract - water-soluble extract, alcohol extract, tannin, eucalyptol, volatile oil
Characteristic spectrum or fingerprint - thin layer chromatography, high performance liquid chromatography, gas chromatography
Determination - the chemical composition of the monomer, polysaccharides, amino acids total, total phenols, total saponins, total alkaloids, total flavonoids
Other medicine - heavy metals and toxic elements, pesticides, sulfur dioxide, residual solvent, aflatoxin, pigment
Structure determination - mass spectrometry, high resolution mass spectrometry, NMR, 13C NMR, spectroscopy fluorine, phosphorus spectrum, a full set of spectra, elemental analysis
Physical constants - melting point, optical rotation, PH value, conductivity
Detection method:Spectroscopy, chromatography, mass spectrometry, determination of physical constants, limited inspection method, other methods of traditional Chinese medicine
Testing Equipment:HPLC、UHPLC、GC、LC-MSMS、LC-TOF、GCMS、UV、VWD、DAD、ELSD、FLD、FID、MSD、NMR
Aptitude test:Certification measures CMA, CNAS Laboratory Accreditation
Inspection process:Customer inspection requirements → provide relevant information → technician contract review → customer service contract offer → two sides signed the inspection contracts → provide test samples → testing personnel detection and analysis → Quality Quality personnel control → authorized officer to issue test reports → customer service delivered to the client .
Medicine technical services
Technical Project:Drug development and formulation Detection
Drug quality standard analytical method validation
Pharmaceutical raw materials and preparations to establish quality standards
Drug research and formulation stability test
Limited development of Chinese medicine harmful residues
Experimental study on compatibility of Medical Packaging
Guiding Principles:ICH guidelines, FDA guidelines, CFDA guidelines, USP guidelines, CHP guidelines
Quality System:ISO / IEC: 17025 quality management system
Service Process:Customer project requirements → provide relevant information → technician contract review → customer service contract offer → two sides signed a technical services contract → provide research samples → project personnel to carry out research projects → Quality Quality personnel control → authorized officer to issue findings projects → customer service delivered to customers.
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