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In the process of drug manufacturing, a large number of solvents will be used, and if not handled properly, the solvents will remain in the drug. When the level of residual solvent in the drug is higher than the safe value, it will cause harm to the human body or the environment. Therefore, in order to ensure the quality and safety of drugs, it is necessary to accurately measure the type and quantity of residual solvents in drugs. The reagent residues analytical standards are essential for the analysis of residual solvents in drugs. The reagent residues analytical standard is a class of highly pure substances with one or more eigenvalues. Normally, the reagent residues analytical standards are liquid. In the actual use process, according to the specific test requirements, the reagent residues analytical standards can be diluted to get a series of different solubility of the standard solutions. Commonly used reagent residues analytical standards include benzene, chloroform, dioxane, ethylene oxide, dichloromethane, trichloroethylene, acetonitrile, pyridine, toluene and others.
Gas chromatography: The main application of reagent residues analytical standards is to measure residual solvents in drugs by gas chromatography. This method has the advantages of good separation ability and high sensitivity. Gas chromatography for the detection of residual solvents in drugs can be divided into three categories, including direct injection gas chromatography, headspace gas chromatography and solid phase microextraction gas chromatography. The most recommended method in the national pharmacopoeia is headspace gas chromatography. When gas chromatography is used for the analysis of residual solvents in pharmaceutical products, it is necessary to draw a standard curve with reagent residues analytical standards. Residual solvents in drugs can be detected by comparing the peak position and peak area of the substance to be measured with the standard curve. For example, it has been reported that gas chromatography can detect 44 residual solvents within 30 minutes based on reagent residues analytical standards.
Alfa Chemistry is one of the largest providers of reagent residues analytical standards in the world and the quality assurance is of prime importance to Alfa Chemistry. The solvent from Alfa Chemistry in the world is synonymous with reliability and excellent quality. Because of the exacting nature of our business and the regulatory demands placed upon our industry, Alfa Chemistry continues to be at the forefront in terms of compliance, accreditations and certifications.