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Tianjin GuoCe Aerospace Technology Co., Ltd.

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Biopharmaceutical testing

  • Hot Line:18322499311

 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/> 

Service Content

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

CategoryDetection items
IdentificationTLC 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 ingredientsPlant 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 metalsMinerals: 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 propertiesColor, 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 toxinAflatoxin (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 residuesOrganochlorine pesticide residues, organophosphorus pesticide residues, pyrethroid pesticide residues, etc
Veterinary drug residuesSulfonamide drugs, ofloxacin drugs, tetracycline drugs, nitrofuran drugs, etc
Microbial testingTotal 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 analysisTotal 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
OtherMicrobial limit testing, sterility testing, antibacterial effect testing, traditional Chinese medicine fingerprint analysis, etc

 



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