The quality and quantity of drugs not only determine the effect of disease prevention and treatment, but also directly affect the safety of patients. Therefore, a clinical drug should have qualified quality to ensure safe and effective use, which is the reason why drug quality must be strictly controlled.
Drug quality control standards shall include the following main contents:
Properties: record various physical and chemical properties of drugs, generally including appearance color, solubility, crystal form, melting point, relative density, refractive index, light absorption coefficient, etc., which are the characteristics of drugs;
Identification: mainly from the consideration of chemical reaction. According to the category reaction or characteristic reaction of the drug, it generates specific color or product with a certain reagent. Sometimes it needs to be combined with UV or infrared spectrum to help identify whether the tested product is consistent with the product name;
Inspection: the impurity items to be inspected are mainly based on the raw materials used in the production of the drug, preparation methods, storage containers and storage processes, as well as possible changes. Considering the possible impurities and the toxicity of these impurities, it is put forward after comprehensive consideration. Generally, there is a certain limit for impurities, and the content of impurities in drugs cannot exceed this limit;
Content determination: it mainly determines the content of effective components in drugs.
Pnt has a professional technical team, has established long-term friendly technical cooperation with many well-known pharmaceutical enterprises at home and abroad, as well as national, provincial and municipal scientific research institutes and universities, and has accumulated rich experience in many fields. For drug quality control, items such as drug label, character, characteristic map, heavy metal, pesticide residue, mycotoxin, solvent residue and relevant component analysis can be carried out.