Have you ever wondered what Pharmaceutical Impurity Reference Standards are, and why they are important? Pharmaceutical Impurity Reference Standards (PIRS) are sets of samples that have been prepared under carefully controlled conditions to contain the impurities which may be found in pharmaceuticals.
They can help companies evaluate their manufacturing processes or products for quality purposes. This article will explain Pharmaceutical Impurity Reference Standards, including how they work and what to look out for when using them.
How do they work? they are used to identify, characterize and quantify the impurities present in a pharmaceutical. The standards can be used as-is or prepared into samples which can then be analyzed by various methods such as chromatography, spectroscopy, and mass spectrometry.
What to look out for when using them? they are not always as straightforward to use as they may initially sound. Pharmaceutical companies should ensure that the reference material supplier is capable of providing their products in a manner which:
- Is certified by an organization such as Pharmaco or USP
- Have been tested and passed before releasing for analysis purposes
In conclusion, Pharmaceutical impurity reference standards play an integral role in Pharmaceutical analysis. They can be used to specify the levels of particular substances which are present within a pharmaceutical product, and ultimately help drug manufacturers create high-quality products for their consumers.