Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
Here are five ways to ensure a successful and compliant cleaning validation program.
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.