What You Need to Know about Computerized System Validation: GAMP 5 2nd Edition
A thorough look at the contents of GAMP 5 Version 2 release to examine what has changed since the Version 1 release.
Pharma Quality Assurance
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Understanding of USP updates and insights in regulations
Learn about how USP <1058> aligns with GAMP® 5, the core elements of the <1058> instrument life-cycle framework, and areas of <1058> the USP are exploring improvements.
Applying Single Quad LC-MS to a Variety of Pharmaceutical and Food & Beverage Analyses
eBook highlighting a variety of applications related to the pharmaceutical and food and beverage markets, specifically highlighting the capabilities of a compact, yet powerful LC-MS system
Purification of Single-Stranded RNA Oligonucleotides
Learn about the purification of single-stranded RNA oligonucleotides by ion-pair reversed-phase chromatography.
Strategies to Enable and Simplify HPLC Polar Compound Separation
Discover solutions for tackling the most difficult HPLC polar compound analyses using a variety of food and pharma applications
Trace Level Impurities in Pharmaceuticals
Learn more about the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceuticals.
Determination of N-Nitrosamines in Valsartan
A GC-MS method to determine nitrosamines in Valsartan tablets according to US FDA guidelines is described.
Dexamethasone: An HPLC assay and impurity profiling following the USP
A simple, precise, and sensitive RP-HPLC gradient method for establishing traceability and total chromatographic analysis of dexamethasone.
New Reference Materials for Extractables & Leachables Testing
Introducing a series of new reference materials for E&L testing, including a toxic degradation product of Irganox 1010.
[eBook] Pharmaceutical and biopharmaceutical solutions
Discover an effective method for drug quantitation in biological fluids, a high-throughput analysis for simple fractionation and more...
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