Pharmaceutical Analysis

Analysis of Lipid Nanoparticle Composition

Separation Science, in collaboration with Agilent, offers an application note covering a liquid chromatographic method development for the analysis of the lipid components of patisiran.

High-Throughput LC/MS Applications

Separation Science, in collaboration with Agilent, offers an eBook focusing on high-throughput LC-MS applications of the RapidFire 400 system. 

Regulatory Challenges in Pharma 4.0

In this forum, the expert panel discuss acceptance from regulators on new technology, and other key issues regarding Pharma 4.0. 

Impact of COVID on Pharma 4.0

In this forum, the expert panel discuss changes to the pharmaceutical manufacturing processes during and post the COVID pandemic including what technologies have been adopted to increase speed and efficiencies. 

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.

Difluoroacetic Acid as an Effective Mobile Phase Modifier for the LC-UV/MS Analysis of Proteins

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, difluoroacetic acid (DFA) is discussed as a suitable alternative to TFA and FA for LC-UV/MS analysis.

Extractables Study with LC-UV/MS

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, an LC-UV/MS method is presented using a corresponding E&L certified reference material (CRM) mix for the LC determination of extractables and leachables.

Three Methods for Critical Quality Attribute Determination of Monoclonal Antibodies

In this article, from Issue 12 of the Analytix Reporter, produced by Merck, three step-by-step protocols to monitor critical quality attributes (CQAs) of monoclonal antibodies were developed using adalimumab as an example.

Dissolution: Today, Tomorrow & Beyond

Separation Science collaborates with industry thought leaders in a series of expert presentation and discussion forums - 'Advancing Pharmaceutical Technologies'. Presenting events that enable molecular spectroscopy approaches to key challenges in...

An Optimized Protocol for Peptide Mapping of Therapeutic Monoclonal Antibodies

Conventional protein digestion procedures used in peptide mapping are lengthy and introduce significant amounts of oxidation and deamidation artifacts. In this article, from Issue 11 of the Analytix Reporter, produced by Merck, the optimized...

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...

PREP 2022 Symposium + Exhibit on Preparative & Process Chromatography

We look forward to seeing you at PREP2022 to be held at the Hyatt Regency Inner Harbor Hotel in Baltimore, MD, USA, on May 15-18, 2022. Find out more about what's going on and why you should be attending... PREP is the longest-running, now in its...

Solutions for Medicinal Chemistry

 

Separation Science, in collaboration with Shimadzu, offers a series of application notes covering everything from a high efficiency workflow for simple fractionation, examples of preparative purification and comprehensive fractionation of herbal...

Facilitating Data Integrity & Compliance

Separation Science collaborates with industry thought leaders in a series of expert presentation and discussion forums - 'Advancing Pharmaceutical Technologies'. Presenting events that enable molecular spectroscopy approaches to key challenges in...

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