Pharmaceutical Analysis

What You Need to Know about Computerized System Validation: GAMP 5 2nd Edition

This webinar takes a look at the contents of the long awaited GAMP®5 Version 2 release to examine what has truly changed since the Version 1 release, with special focus on what might impact regulated laboratories in the pharma, biopharma, and...

Understanding of USP<1058> 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 in by attending this upcoming webinar.

Purification of Single-Stranded RNA Oligonucleotides

In this application note purification of a single-stranded RNA oligonucleotide by ion pair reversed-phase HPLC is demonstrated, achieving > 99% pure fraction pool with a yield of > 56%.

Trace Level Impurities in Pharmaceuticals

This virtual forum discusses the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products including mutagenic nitrosamine impurities.

Determination of N-Nitrosamines in Valsartan

The recent years have witnessed the emergence of nitrosamines as a serious contaminant group in APIs from the sartan family. In this article, from Issue 11 of the Analytix Reporter, produced by Merck, a GC-MS method to determine nitrosamines in...

Dexamethasone: An HPLC assay and impurity profiling following the USP

This article from Issue 9 of the Analytix Reporter, produced by Merck, provides a simple, precise, and sensitive reversed-phase high performance liquid chromatography (RP-HPLC) gradient method for establishing traceability and total chromatographic...

New Reference Materials for Extractables & Leachables Testing

This article from Issue 10 of the Analytix Reporter, produced by Merck, introduces a series of new reference materials for E&L testing, including a toxic degradation product of Irganox 1010.

[eBook] Pharmaceutical and biopharmaceutical solutions

This eBook contains a selection of application notes relevant for pharmaceutical and biopharmaceutical analysis using HPLC / (U)HPLC or LC-MS/MS.

Latest Solutions for Nitrosamine Analysis

Separation Science, in collaboration with Shimadzu, offers a series of application notes describing the quantitation of various nitrosamines in drugs and solvents using its LC/MS or GC/MS instruments. Click below to download your personal copies.

[Webinar] Analytical Methodologies for Nitrosamines: Challenges and Solutions

This on-demand webinar presents a case study of risk assessment implementation and covers analytical methodologies for N-nitrosamines with their challenges and suggested solutions. By watching this presentation you will: 1) Get background...

Broughton Nicotine Services accelerating science through innovation

This case study describes how Broughton Nicotine Services, a Contract Research Organization (CRO) utilizes a number of state-of-the-art technologies able to meet the analytical needs of their clients including Vanquish UHPLC platforms coupled to TSQ...

Reliably quantify nitrosamine impurities in drugs using an HRAM LC-MS method

This application note will enable you to detect and quantify nine nitrosamines with a single liquid chromatography-high resolution accurate mass (HRAM) mass spectrometry method.

Continuous Manufacturing: Business Case Drivers, Control and Deployment Strategies for Small Molecule Oral Products

With the move from traditional batch manufacturing to continuous manufacturing there is a need for real-time monitoring and real-time release of products - learn more from Janssen Pharmaceuticals.

[Webinar] How Can LIMS Deliver Value to Your Pharma Manufacturing Lab?

Separation Science, in collaboration with Thermo Fisher Scientific - Digital Science, offers a webinar focusing on how laboratory information management systems (LIMS) can deliver value and efficiency, and increase productivity, in your...

How to Select a Reproducible Starting Point in HPLC Method Development

Separation Science, in collaboration with Phenomenex offers an on-demand webinar 'HPLC/UHPLC Reversed-Phase Method Development: Selecting a Reproducible Starting Point' with pharma industry expert, Dr Phil Koerner.

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