Particle purity is a measure of the extent to which a given particle is free from contaminants. In the cases of pharmaceuticals, that means measuring the degree to which impurities, such as other active ingredients, excess amounts of excipients, foreign materials, and packaging materials, are present in a drug’s active ingredient or formulation. Impurities can have a negative impact on a drug’s efficacy, potency, and even safety. For this reason, drug manufacturers must ensure that the drugs they produce meet specified purity levels.
To measure the particle purity of a drug’s active ingredient, manufacturers typically use a variety of analytical techniques, including High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) and Liquid Chromatography/Mass Spectrometry (LC/MS). These techniques are able to detect trace contaminants, down to parts per million (ppm). This level of detection allows manufacturers to ensure that their drugs meet stringent purity requirements.
In addition to analyzing the active ingredient, drug manufacturers also need to measure the particle purity of the finished drug product. This is done by analyzing sample batches of the finished product, using techniques such as quantitative laser diffractometry, particle size analysis, optical microscopy, and imaging techniques. This ensures that any potential contamination, such as those caused by poor production process, has been eliminated.
The particle purity of the active ingredient and the finished product both need to be regularly monitored, to ensure that they maintain the required levels of purity. In addition, manufacturers need to be aware of any changes in manufacturing procedures and processes, which can have an impact on particle purity levels.
In conclusion, particle purity is a critical factor in drug manufacturing. It is important that manufacturers inspect the active ingredient and the finished product for impurities, and regularly maintain particles purity levels. By ensuring particle purity, manufacturers can ensure that their drugs are safe and effective.
