Total Nitrogen Measurement in Biopharmaceuticals

This article is a technical report detailing the application of Total Nitrogen Measurement (TNM) as an analytical technique for estimating protein content in biopharmaceutical products, specifically vaccines. Conducted at the Serum Institute of India Pvt. Ltd., the study emphasizes the importance of nitrogen measurement in proteins, which are essential for vaccine production. The report outlines the conventional Kjeldahl method for protein nitrogen estimation, noting its limitations, such as the need for correction factors and safety hazards associated with its use. An alternative method using high-temperature combustion and chemiluminescence detection is presented, offering a faster and safer approach for nitrogen analysis. The article compares results from the TNM method with those from the Kjeldahl method, demonstrating comparable outcomes in terms of protein estimation accuracy. The findings suggest that the TOC-L analyzer equipped with TNM-L can be effectively utilized for nitrogen estimation in various nitrogen-containing pharmaceutical products.