Inorganic impurities are key attributes that describe the quality of a drug and can directly affect the safety and effectiveness of the product. Inorganic impurities should be checked by modern separation analysis. In the research phase of impurity analysis, possible impurities, forced degradation products, are added to the main components, test solutions are prepared for chromatographic analysis, chromatographic conditions are optimized, applicability requirements are determined, and the method is guaranteed to be exclusive and sensitive. CD Formulation provides customers with the separation, detection, and identification of a wide range of impurities to help them perform better and faster drug development.
Inorganic impurities refer to impurities such as reagents, ligands, catalysts, metal impurities, inorganic salts, filter aids, and activated carbon in pharmaceuticals. According to the nature, inorganic impurities can be divided into two categories: one is generally harmless, but the amount of its content can reflect the level of purity of the drug signal impurities or indicative impurities, such as chloride, sulfate, etc.; the other is harmful to humans, or can accumulate in the body of harmful impurities, mainly refers to arsenic salts, heavy metals, etc. Inorganic impurities in the storage process is relatively unlikely to be introduced in the stability study can generally not be examined, mostly introduced by the production process. In the production process of pharmaceutical APIs, commonly used acids, bases, reaction reagents, catalysts, etc. are introduced; metal utensils, pipes and other metal tools used in the production process that are not resistant to acids and bases may introduce metal impurities; inorganic salts, filter aids, activated carbon, etc. are introduced in the production. Inorganic impurities are generally known and identified.
Based on CD Formulation's extensive experience in the analysis of inorganic impurities, we can provide our clients with inorganic impurity analysis services for drugs, including the detection of inorganic anions, metal ions, etc., to help our clients quickly analyze the composition and content of impurities in drugs. At the same time, we can also conduct impurity studies, analyze the source of impurities, impurity treatment and process optimization for impurity removal in drug development for our clients.
including chloride examination method, sulfate examination method, sulfide examination method, fluorine examination method, cyanide examination method, etc.
including iron salt inspection method, ammonium salt inspection method, arsenic salt inspection method, heavy metal inspection method, etc.
In addition to the above inorganic impurity detection, if you have a need, please contact our staff in time. Our scientific staff will customize the impurity detection method for your drug to help you perform the analysis of your drug quickly.
In the process of drug development, the quality of the drug must be strictly controlled to keep the impurities within the specified limits. This can be achieved through strict control of the synthesis route and production process, as well as physical or chemical removal of impurities to improve the quality of the drug.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.