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Pharmaceutical impurities refer to other chemical substances other than active ingredients introduced or produced in the process of drug production and storage, which may cause adverse side reactions and affect the efficacy of drugs. Analyzing the type and content of pharmaceutical impurities can guide to optimize the synthetic route, experimental conditions and other factors, which can be used to avoid producing pharmaceutical impurities or reduce them to a minimum. Pharmaceutical impurities certified reference material is a kind of reference substance widely used in the analysis of pharmaceutical impurities. As a kind of physical reference material, the pharmaceutical impurities certified reference material has certain confidence. In addition, a certificate is attached to each pharmaceutical impurity certified reference material, which records the required information. Furthermore, the characteristic values of pharmaceutical impurities certified reference materials are determined by specific procedures, which makes them are traceable. Frequently used pharmaceutical impurities certified reference materials include acetaminophen impurities, aspirin (acetylsalicyclic acid) impurities, diphenhydramine hydrochloride impurities, lidocaine impurities, paracetamol (acetaminophen) impurities, naproxen impurities and others.
Thin layer chromatography (TLC): Thin layer chromatography (TLC) is widely used in the analysis of pharmaceutical impurities with the advantages of easy operation, simple equipment, high separation efficiency, good specificity and fast analysis speed. In addition, pharmaceutical impurities certified reference materials are essential standard samples in TLC analysis. For example, it is possible to detect ibuprofen enantiomer impurities using TLC by comparing them with pharmaceutical impurities certified reference materials.
Gas chromatography (GC): Gas chromatography (GC) is a simple and low-cost method, which is commonly used to analyze impurities in drugs that are heat stable, volatile, or high temperature vaporizable. For example, a gas chromatography method is established to detect three impurities in rimantadine hydrochloride. In the process of testing, pharmaceutical impurities certified reference materials are required.
High performance liquid chromatography (HPLC): High performance liquid chromatography (HPLC), as a mature analytical method for the detection of impurities in drugs, has the characteristics of high separation efficiency, high sensitivity, good selectivity, fast analysis speed, wide application range and others, which has been adopted by the pharmacopoeia of various countries. During HPLC detection, it is usually necessary to establish standard curves with pharmaceutical impurities certified reference materials. According to the peak position and peak area of the standard curves, the quantitative and qualitative analysis of pharmaceutical impurities can be realized. For example, based on the standard curves established with pharmaceutical impurities certified reference materials, reversed-phase HPLC and chiral HPLC can be used to determine related impurities in silodosin.
Others: In addition to the above application fields, pharmaceutical impurities certified reference materials are also widely used in other fields, such as gas chromatography-mass spectrometry, liquid chromatography-mass spectrometry and others.
Alfa Chemistry is one of the largest providers of pharmaceutical impurities certified reference materials 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.