Biopharmaceutical Impurities Analysis Service

Testing, identifying, quantifying, and controlling pharmaceutical impurities are crucial for ensuring the purity, safety, and quality of both drug substances and finished drug products. Pharmaceutical impurities originate from a variety too. This includes starting materials and their contaminants, reagents, catalysts, solvents, intermediates, excipients, leachables, and degradation products. These contaminants may be organic, related either to the process or the drug, or they could be inorganic or elemental impurities. 

 

Since these impurities are often present at very low or trace levels in complex sample matrices, highly sensitive and specific analytical techniques must be used.These methods are essential not only for determining impurity levels but also for gathering the necessary data to conduct relevant risk assessments or to fulfill regulatory submission requirements. A prominent concern in this area includes nitrosamine-related impurities, such as N-Nitrosodimethylamine (NDMA), which have been identified by the US FDA as significant due to their potential formation during the manufacturing process.

 

MtoZ Biolabs offers pharmaceutical impurity analysis for both new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)), supporting product development from initial stages through to the entire lifecycle of the drug product.Our services include professional analysis for extractables and leachables, testing for elemental impurities, analysis of residual solvents (OVI or VOC), and identification of process-related impurities.Furthermore, we specialize in the highly sensitive and specific development and validation of methods aimed at detecting and controlling genotoxic impurities, such as nitrosamines. For biologic therapeutics, we deliver comprehensive services to determine bioprocess residuals and biopharmaceutical product-related impurities.

• • SEC and RPLC Based Protein Purity Analysis Service

  MtoZ Biolabs has established a platform with both SEC and RPLC technologies, to meet the requirements of analyzing various biopharmaceutical samples.