Pharmaceutical testing capability
Testing of active substances and impurities
There are many types of impurities in drugs, such as substances related to the structure of raw materials, intermediates in the synthesis process that may be genotoxic impurities, solvents used that may produce residues and become solvent residue impurities, metal catalyst residues and metal equipment contact that may become elemental impurities. These impurities can have an impact on the safety of drugs
< In addition, the content of active substances in drugs is a key factor in treating diseases, and sufficient doses are necessary to achieve therapeutic effects. However, due to the significant differences in composition and structure, the corresponding methods for determining specific content vary, requiring different instruments and detectors, as well as experienced analysts< br/>
1. Testing of active substance content< 2. Research and testing of elemental impurities< III. Establishment and validation of methods for genotoxic substances< Fourth, solvent residue testing< br/> < Traditional Chinese Medicine Testing
Category | Detection items |
Identification | TLC identification, paper chromatography identification, gas chromatography identification, liquid chromatography identification, infrared spectrum identification, microscopic identification of Chinese medicinal materials, microscopic identification of traditional Chinese patent medicines and simple preparations |
Active ingredients | Plant active ingredients: flavonoids, volatile oils, steroids and glycosides, alkaloids, sugars, etc< Active ingredients of animal medicine: bile acids, taurine, muscone, muscol, etc |
Minerals and heavy metals | Minerals: sodium (Na), potassium (K), calcium (Ca), magnesium (Mg), iron (Fe), zinc (Zn), phosphorus (P), etc< Analysis of harmful heavy metals: arsenic (As), lead (Pb), cadmium (Cd), mercury (Hg), copper (Cu), etc |
General physical and chemical properties | Color, odor, pH value, purity, clarity, content uniformity, impurities, moisture, ash content, acid value, peroxide value, iodine value, density, solubility, melting point determination, burning residue, drying loss, evaporation residue, potassium permanganate consumption, appearance, Chinese herbal medicine properties, etc |
Fungal toxin | Aflatoxin (B1, B2, G1, G2), ochratoxin and mycotoxins, penicillin, vomitoxin, zearalenone, ochratoxin A, free gossypol, polychlorinated biphenyls, nitrite, nitrate, sulfite, N-nitrosamines, benzo (a) pyrene, 3-chloro-1,2propanediol, acrylamide, trans fatty acids, inorganic arsenic, methylmercury, bromate, formaldehyde, acetaldehyde, glyoxal, cyanide, sulfur dioxide, suspended white blocks, quinoxaline, histamine, petroleum hydrocarbons, trimethylamine nitrogen, Sudan red, melamine and cyanuric acid, phthalates. 4-methylimidazole, L (-) hydroxyproline, etc |
Pesticide residues | Organochlorine pesticide residues, organophosphorus pesticide residues, pyrethroid pesticide residues, etc |
Veterinary drug residues | Sulfonamide drugs, ofloxacin drugs, tetracycline drugs, nitrofuran drugs, etc |
Microbial testing | Total bacterial count, coliform group, total coliform group, heat-resistant coliform group, Escherichia coli, pathogenic bacteria (Salmonella, Shigella, Vibrio parahaemolyticus, Staphylococcus aureus, Streptococcus pyogenes), Clostridium perfringens, Bacillus cereus, mold, yeast, commercially sterile, Listeria monocytogenes, lactic acid bacteria, Escherichia coli, Streptococcus faecalis, Pseudomonas aeruginosa, Bifidobacterium, etc |
Component analysis | Total saponins, total flavonoids, matrine, oxymatrine, inositol, ginsenosides, salidroside, aloin, paeoniflorin, lovastatin, L-carnitine, anthocyanins, grape polyphenols, soy isoflavones, chondroitin sulfate, crude polysaccharides, 10 hydroxy -& alpha;- Decanoic acid, allicin, puerarin, lycopene, geniposide (gardenoside), chromium picolinate, cordycepin, silymarin, triterpenoids, melatonin, sorghum ginger extract, poplar extract, lotus leaf alkaloid, adenosine, berberine, crude polysaccharides, superoxide dismutase (SOD), Ganoderma lucidum polysaccharides, Ganoderma lucidum triterpenoids, caffeine, aconitine, chlorogenic acid, tanshinone IIA, gastrodin, emodin and emodin, vitamins, minerals, etc. in propolis solution |
Other | Microbial limit testing, sterility testing, antibacterial effect testing, traditional Chinese medicine fingerprint analysis, etc |