この記事の概要
A number of analytical methods are used to verify that manufactured drugs meet quality standards. These methods play an important role in the pharmaceutical industry, assuring the safety, efficacy, and purity of drugs. Some of the major analytical methods are listed below:
A number of analytical methods are used to verify that manufactured drugs meet quality standards. These methods play an important role in the pharmaceutical industry, assuring the safety, efficacy, and purity of drugs. The major analytical methods are listed below:
- High performance liquid chromatography (HPLC):.
- HPLC is a widely used technique for identification, quantitation, and purity evaluation of components. It is very effective in analyzing drug components and detecting impurities. This method is the most commonly used method for drug component analysis. For more information, please click here.
- Gas chromatography (GC):.
- GC is particularly suited for analyses involving volatile components. It is used to check purity and analyze solvent residues.
- Mass Spectrometry (MS).
- MS accurately measures the mass of molecules and is used for structural and quantitative analysis of compounds, often in combination with HPLC and GC.
- Infrared spectroscopy (IR).
- IR is useful for identifying the functional groups of a compound and is used to confirm the chemical properties of a product.
- Ultraviolet Visual Spectrophotometry (UV-Vis).
- UV-Vis spectroscopy is used to determine the concentration of a drug, specifically to measure and quantify the absorbance of a component in solution.
- Nuclear Magnetic Resonance Spectroscopy (NMR):.
- NMR is used to analyze the molecular structure of a drug in detail and provides a very accurate understanding of the molecular environment of a compound.
- Solubility test
- It measures solubility, which affects the drug’s effectiveness in the body.
- Stability test
- Evaluates how stable a drug is under specified storage conditions and contributes to the establishment of a shelf life.
Through these analytical methods, they verify that the manufactured drugs are safe and effective, in compliance with legal regulations and guidelines. Pharmaceutical companies submit the results of these tests to regulatory authorities to ensure that the drugs are safe for patients as they move through the approval process and onto the market.
