The importance of Nitrogen purity testing in the pharmaceutical industry
Nitrogen purity testing is important in the pharmaceutical industry for several reasons. Nitrogen is commonly used in the pharmaceutical industry for various purposes, such as in the manufacturing process, storage, and transportation of pharmaceutical products. In these applications, the purity of nitrogen is critical to ensuring the quality and safety of pharmaceutical products.
Firstly, nitrogen is often used to create an inert atmosphere during the manufacturing process of pharmaceutical products. An inert atmosphere helps to prevent the degradation of the active pharmaceutical ingredients and the growth of microorganisms. If the nitrogen used is not of sufficient purity, it may contain contaminants that can react with the active pharmaceutical ingredients, leading to the production of impurities or degradation products. This can affect the efficacy and safety of the final product.
Secondly, nitrogen is commonly used in the packaging of pharmaceutical products to create a protective atmosphere. The purity of nitrogen used in this application is critical to prevent the oxidation or moisture of the pharmaceutical products, which can lead to degradation and reduce the shelf-life of the product.
Thirdly, nitrogen is used in the transportation and storage of pharmaceutical products to create a controlled environment. The purity of the nitrogen used in this application is essential to prevent contamination of the pharmaceutical products during transportation or storage. Contaminants such as microorganisms or particulates can affect the quality and safety of the product, leading to potential health risks for patients.
In conclusion, nitrogen purity testing is crucial in the pharmaceutical industry to ensure the quality and safety of pharmaceutical products. It helps to prevent degradation, contamination, and other issues that can affect the efficacy and safety of the final product. Pharmaceutical manufacturers should establish proper testing protocols and adhere to them consistently to ensure that the nitrogen used in their processes meets the necessary purity standards.
Our latest innovation is a portable ultra lightweight GC, weighing 4 kgs for Nitrogen purity estimation with built-in gas sampling valve to estimate Nitrogen impurity right at the source of Nitrogen supply. It has become a US Pharmacopeial requirement to estimate the purity of Nitrogen, which is used as a carrier gas in Gas Chromatography. When sampling the gas, it is important that the sample collection is done without any environmental contact or exposure to ensure that the real impurity profile is captured. Gas transportation with gas sampling bomb, gas sampling bag, such as Tedler bags, are prone to cross contamination. Regular Gas Chromatographs are quite bulky to be taken close the cylinder bank and it is impractical for the cylinders themselves to be carried into the laboratory.
Take a look at the Mayura Analytical Portable Nitrogen tester. This portable GC is mainly used in Pharma to test the purity of Nitrogen at the source bank. Check out more details about our Portable Nitrogen Analyser here
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Gases can be directly sent to the GC without any cross contamination without a syringe injection. The Thermal Conductivity Detector (TCD) built into the GC will determine up to few PPM of Oxygen in Nitrogen Gas, thereby providing accurate and reliable results. An easy carry compact carrier gas cylinder of 500 mL volume and a mini laptop will ensure the ease of analyses. The GC works on DC 12V car battery or AC 230 V.