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Welcome to Pharma Science

 
 

Pharma Science is a global learning portal for fundamentals, best practice and troubleshooting information for analytical scientists working in the pharmaceutical industries. Featuring articles, applications, webinars, eSeminars and other online tools Pharma Science is the 'go to' information resource.

 
 
 
 

Learning Materials

 

Solutions

Direct analysis in real time – High resolution mass spectrometry as a valuable tool for the pharmaceutical drug development

Exploring the application of direct analysis in real time mass spectrometry (DART-MS) for drug development, Jan Srbek et al. Working on behalf of the major pharmaceutical company Zentiva, conducted an in-depth investigation of the suitability of this anaylitical technique.

 

Coupling ultra-high-pressure liquid chromatography with mass spectrometry for in-vitro drug-metabolism studies

Drug metabolism studies are a crucial phase of the drug discovery process. Serge Rudaz  et al  conducted an investigation into how UHPLC can be coupled with MS for rapid, reliable analysis.

 

HPLC Solutions #33: Column Failure – Regeneration

Earlier this spring, I was in London, teaching an HPLC troubleshooting class in conjunction with Separation Science . I love to teach, so the presentation of short courses is one of the highlights of my job...

 

Titration Solutions #6: Points to Consider Before Starting Titrations

When you have to do an analytical experiment the first thing to do is always to ask if others done the same thing before. You may consider standard works or look at literature on- or offline. Maybe you don’t find the recipe for your exact substance  but you study a similar one. At the end you see that you have to develop a new method and validate it also. Nevertheless some of the following points apply to standard methods or to new ones.

 

Chemometric analysis of correlations between electronic absorption characteristics and structural and/or physicochemical parameters for ampholytic substances of biological and pharmaceutical relevance

Jerzy Blazejowski et al of the University of Gdańsk Poland conducted an investigation into Chemometric analysis of correlations between electronic absorption characteristics and structural and/or physicochemical parameters for ampholytic substances with a particular focus on pharmaceutical relevance.

 

HPLC Solutions #1: All Columns are NOT Created Equal

Q: I have a validated stability-indicating assay that uses one manufacturer’s C18 column. I know of another column manufacturer where I can get an equivalent C18 column for half the price of the column stated in the method. Will changing columns invalidate the method?

 

Critical evaluation of fast size exclusion chromatographic separations of protein aggregates, applying sub-2 μm particles

Szabolcs Fekete et al of the university of Geneva, Switzerland carried out an investigation into size exclusion chromatography for the analysis of protein aggregates. This covered many aspects of SEC such as the analytical conditions and detectors but also its application to biopharmaceutical analysis

 
 

eSeminars

ON-DEMAND


Analytical Challenges for Biosimilar Development

 Sponsors:   Agilent Technologies

Pharma Science, in collaboration with sponsors Agilent Technologies, has developed an online eSeminar focusing on the analytical and bioanalytical challenges posed by the biosimilar development process. This educational resource will provide pharmaceutical and biopharmaceuticals scientists with updates on the latest issues faced by individuals working in this complex field by bringing together some of the leading biosimilar experts and providing an interactive learning environment and online resource.

Protein Analysis Methods for Biopharmaceuticals

 Sponsors:   Tosoh Bioscience GmbH

Pharma Science, in collaboration with Tosoh GmbH, has developed and online eSeminar focusing on analytical methods for the analysis of proteins as part of the process of Biopharmaceutical development. This educational resource offers full access to a selection of presentations from leading scientists around the world, offering advances in methods and applications pertaining to this complex analytical field.

Advances in Analytical Methods for Biotherapeutics

 Sponsors:   PSS

Pharma Science, in collaboration with PSS, has developed an on-demand eSeminar focusing on analytical and bioanalytical methods for the analysis of biotherapeutic proteins. This educational resource offers full access to a selection of presentations from leading scientists around the world, offering advances in methods and applications pertaining to this complex analytical field.

Applications

Using Longer Aeris PEPTIDE Core-Shell HPLC/UHPLC Columns for Improved Peptide Mapping

A new 3.6 µm 100 Å HPLC/UHPLC column (Aeris PEPTIDE) has been introduced that is specifically designed to improve separations of peptide and peptide mapping applications.

 

Increasing Peak Capacity in Reversed-Phase Peptide Separations with Charged Surface Hybrid (CSH) c18 Columns

Peptide separations are of paramount importance, whether studying proteins by bottom-up proteomics or thoroughly characterizing biopharmaceuticals using peptide mapping. The mixtures encountered in these analyses are inherently complex. Reversed-phase (RP) chromatography has become the separation mode of choice, as it offers relatively high resolving power and easily interfaces with mass spectrometry (MS).

 

Fast Nevirapine Impurity Profiling Using UHPLC-DAD

Here we report optimization of the United States Pharmacopeia HPLC-UV approach to determine nevirapine and its impurities by using a state of the art gradient UHPLC-UV method.

 

Extraction of Antiepileptic Drugs from Serum and Urine using ISOLUTE® SLE+ Prior to LC-MS/MS Analysis

This application note describes the extraction of neutral and zwitterionic antiepileptic (AED) drugs from serum and urine using ISOLUTE SLE+ in a 96-well plate format. The method demonstrates a quick, simple and clean analysis with high levels of recovery achieved.  Using a 96-well plate format facilitates a high throughput work flow model.

 

Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling

Residual solvents were detected by following the USP 467 method using a new valve and loop autosampler configured with a solid, fully integrated, and reliable platform with full auditing capability.

 

An Alternative USP Method for the Analysis of Impurities in Riboflavin (Vitamin B2) Using LC-MS/MS

Riboflavin (vitamin B2) is a water-soluble vitamin. It is synthesized by all plants and many microorganisms, but it is not produced by higher animals. It is a precursor of coenzymes that are required for the enzymatic oxidation of carbohydrates, so it is essential to basic metabolism.

 

Excellent LC-MS Separation of Penicillins and Cephalosporins Using Ultra IBD Columns

Excellent LC-MS Separation of Penicillins and Cephalosporins Using Ultra IBD Columns

Antibiotics are the most widely used medications in the world. Whether by prescription, addition to animal feed stocks, or use of cleaning agents, everyone in the civilized world is either directly or indirectly exposed to antibiotics in daily life.

 
 

Webinars

ON-DEMAND

Applications of New HPLC Particle Technology within The Pharmaceutical Industry

Presenter: Adam P. Schellinger

In a process analytical chemistry environment, high efficiency chromatographic methods are needed to assess the purity of starting materials, intermediates and the drug substance during the development of a synthetic process. Although the environment is not high throughout (e.g., drug screening), fast analysis is required for in-process testing (e.g., reaction completion) to allow processing to continue and maintain product quality, as continuing the reaction may generate impurities (e.g., lower yield and potentially product quality) with minimal benefit of converting reactant to product.
This presentation will highlight some examples of how new column technology such as fused-core particle columns has been used to meet the needs of the process chemistry environment.



Regulated Pharmaceutical Instrumental Analysis - Complete Monograph Methods with AAS, FTIR, HPLC, and KF

Presenter: Patrik Appelblad

Details of updated monograph methods for four selected blockbuster molecules that have recently come off patent, or will do so by 2016. By describing HPLC, FTIR, Karl Fischer Titration, AAS and ICP methods we will show how state-of-the-art products simplify analysis of different types of drugs.



QbD for Pharma Analytical Methods

Speakers include: Phil Nethercote, Melissa Hanna-Brown, Patrik Petersson, Eric Rozet, Cari Sanger, Paul Smith, John Dolan

Applying QbD principles at every stage of development and manufacturing helps enhance process robustness and prevent failures at later stages. This seminar series, produced by Separation Science in collaboration with Agilent Technologies, features industry experts highlighting some of the key drivers for QbD as well as the ways QbD concepts can be applied to help ensure methods are rugged and robust.




Pharmaceutical Applications of Raman Spectroscopy

Presenter: Frederick Long

You will learn about a variety of applications of Raman spectroscopy in the pharmaceutical industry and discover the benefits and limitations of this technique




Analysis of Pharmaceuticals by ICP-MS and WD-XRF

Presenter: Frank Weber

Through application examples of ICP-MS and WD-XRF you will learn how these methods are used for the analysis of inorganic impurities in finished pharmaceutical products




Structural Techniques: Contribution to the Drug Discovery & Development

Presenter: Carla Marchioro

You will learn how structural techniques contribute to drug discovery and development. This will be further explained through application examples.




Classification of Crude Oils and Pharmaceutical Counterfeits: The Powerful Combination of Vibrational Spectroscopy and Chemometrics

Presenter: Peter de Peinder

You will learn about Infrared (ATR), NIR and Raman spectroscopy. Furthermore, chemometric techniques like PCA and PLS will be introduced and you will see how vibrational spectra allows you to monitor material properties even if the information is hidden in your data.


Self-Paced Training

All courses displaying the Royal Society of Chemistry logo have undergone their rigorous accreditation programme. Each course has regular Q and A sessions to validate key learning objectives

Practical HPLC for Biopharmaceuticals

What does it cover?


“Practical HPLC for Biopharmaceuticals” explains chromatography in practical terms from the ground up. Here’s
what you’ll learn in this online course:
• The basics of isocratic and gradient HPLC
• Reversed phase and ion exchange HPLC
• HPLC equipment - from reservoirs/pumps to tubing/injectors to columns and detectors
• Understanding and overcoming common column problems
• Alternative modes: normal phase, HILIC and size exclusion
• Quantitation
• UHPLC
• Performance qualification
• Troubleshooting and diagnostics

HPLC Basics, Equipment, and Troubleshooting

What does it cover?

“HPLC Basics, Equipment, and Troubleshooting” explains chromatography in practical terms from the ground up.
Here’s what you’ll learn in this online course:
• The basic principles of HPLC
• The five fundamental HPLC modes
• The easy and logical way to adjust experimental variables to get a good separation
• The best approach to use for various chromatographic applications
• How to maximize column life
• Special techniques such as gradient elution, quantitation, and sample pretreatment
• The operating principles of each module in an HPLC system
• Proven techniques for systematic problem-solving and instrument maintenance 
• The most effective, timesaving, money saving approaches to preventing
common hardware problems and method failures.


Advanced HPLC Method Development Using Quality by Design

What does it cover?

The central tenant of Quality by Design (ICH Q8) is that quality cannot be tested into a product – instead it must be designed into the product. When the product is an HPLC method, QbD strategies can guide the development process to result in a standardized method development prcedure, more easily validated methods, and methods that are easier to use and adjust in routine applications.
“Advanced HPLC Method Development Using Quality by Design” is an intensive online class that teaches you strategy and technique to develop high-quality HPLC and UHPLC methods quickly and with confidence. You will learn a time-proven technique that walks you through the method development process a step at a time using sound chromatographic principles to help make the process more efficient. The techniques can be used as a stand-alone strategy or added to existing development procedures to help streamline the process. Because the same principles apply to HPLC and UHPLC, you can apply the same information for the development of UHPLC methods.


Introduction to Gas Chromatography

What does it cover?

The ‘Introduction to Gas Chromatography’ On-Line Tutorial is basic introduction to the theory and practice of gas chromatographic analysis. It is designed to bring GC users to a more comfortable and capable level of proficiency in instrument operation, optimization, and troubleshooting. Lessons are presented in a visually engaging and accessible manner through narrated on-line video presentations. In full recognition of the difficulty in setting large blocks of uninterrupted time for training; the lessons are presented in short segments that can be easily fit into even the busiest schedules.
• This course presents the basic processes and instrumentation involved with GC analysis.
• The level of material is specifically designed for GC users without extensive formal training.
• Applicable theory is covered to the extent that it helps guide best practices, method optimization and effective troubleshooting.




Intermediate Gas Chromatography

What does it cover?

The Intermediate Gas Chromatography tutorial is designed for GC users who have a fundamental understanding of how gas chromatography works and who are ready to develop a more in-depth understanding of the technique. As with the ‘Introduction to Gas Chromatography’ course, the ‘Intermediate Gas Chromatography’ course is organized into sections and modules. The sections focus on a given theme and the modular structure underneath exposes students to the information within time-effective sections. The ‘Intermediate Gas Chromatography’ course is a logical next step after completing the ‘Introduction to Gas Chromatography’ course.




LC-MS/MS for Chromatographers

What does it cover?

With the introduction of the mass spectrometer (MS) as a practical detector for a high-performance liquid chromatograph (LC or HPLC) in the early 1990s, LC-MS began to be used for routine applications. One form of LC-MS uses a tandem MS (LC-MS/MS), that has become the go-to instrument for quantitative analysis of drugs in biological matrices in the pharmaceutical laboratory. As they have become more widely used and understood, LC-MS and LC-MS/MS have found their way into environmental applications, synthetic chemistry, protein analysis, and many other areas. LC-MS/MS has moved from a technique available only to skilled experts in both HPLC and MS to a routine tool usable much as any other HPLC detector. You will find that this introductory course in LC-MS/MS will give you a good foundation of understanding the technique and how to use it in your daily work. We start out with an overview of different MS techniques, and focus in the majority of the course on the quadrupole mass spectrometer. You will learn how MS works, how ions are produced and fragmented. Sections focus on qualitative, as well as quantitative analysis. Each part of the process, calibration, tuning, sample preparation, HPLC method development, and MS method development are covered. Many tricks and techniques of practical use are presented.





Principles of HPLC Validation

What does it cover?


This class focuses on validating high-performance liquid chromatographic (HPLC) methods developed for the analysis of pharmaceutical drug substance (pure drugs), drug product (formulated drugs), impurities, and degradation products. It does not focus on bioanalytical methods (drugs in plasma or tissue) – for these, see additional material in Section 11 of LC-MS/MS for Chromatographers. Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods, such as environmental or general chemical analyses

Fundamentals of HPLC

What does it cover?


Fundamentals of HPLC covers the essentials that every scientist needs in order to make effective use of liquid chromatography
instrumentation:
• The basics of the chromatographic process
• Terms and definitions of chromatography
• How HPLC systems work
• Practical tips on preventive maintenance
• Principles of separation chemistry
• Why “reversed phase” is the standard separation technique
• The meaning of “gradients” and why they are used
• How to get the best quantitation
• and much more.



HPLC & UHPLC Troubleshooting: A Performance Qualification Approach

What does it cover?


“HPLC & UHPLC Troubleshooting: A Performance Qualification Approach” is an intensive online course that teaches you the ins and outs of solving problems that occur with your high-performance liquid chromatography (HPLC) and ultra-high pressure liquid chromatography (UHPLC) methods. You will learn how to qualify the performance of your HPLC or UHPLC using specific tests that also can be used for isolating existing problems. More importantly, you’ll learn how to prevent many of these problems from happening in the first place.

Introduction to Capillary Electrophoresis - Fundamentals and Operating Principles

What does it cover?

“Introduction to Capillary Electrophoresis” explains the fundamentals of CE from the ground up. The course comprises:
- The basic principles of capillary electrophoresis
- Ten different modes of CE, including CZE, CGE and cIEF
- Equipment and operational details
- Treatment of the capillary, the separation column
- Electrokinetic and hydrodynamic injection
- Multiple detection mechanisms
- Corrected peak areas explained
- How to get started with method development and how to predict the migration order
- Tips for successful implementation of CE in your lab




GC-MS for Operators and Developers

What does it cover?


‘GC-MS for Operators and Method Developers’ is specifically designed for GC users and operators. Fundamental
principles, when presented, are done so with a focus on the practical aspects and applications as might be
applied on a daily basis.
The ‘Intermediate Gas Chromatography’ course is a logical next step after completing the ‘Introduction to Gas
Chromatography’ course.


Technology

Chromolith® Technology Microsite

Learn more about the revolutionary monolithic silica columns – Chromolith®. Read interesting details about fast HPLC applications providing excellent results, thus saving time and money.





CORTECS® Solid-Core Technology

Learn more about CORTECS® solid-core particle columns from Waters, which offer particle sizes ideal for HPLC, UHPLC, and UPLC platforms. These columns are developed for a simple, seamless method transfer with consistent results across different particle sizes and column configurations.

Our Events

Spectroscopy Solutions 2014 eConference

This online event focuses on key disciplines within atomic and molecular spectroscopy providing attendees with an exclusive learning opportunity from eminent thought leaders and key educators in these techniques. Many of the presentations have a specific focus on the pharma industry.

 
 
 

Applications of New HPLC Particle Technology within The Pharmaceutical Industry

Overview:
In a process analytical chemistry environment, high efficiency chromatographic methods are needed to assess the purity of starting materials, intermediates and the drug substance during the development of a synthetic process. Although the environment is not high throughout (e.g., drug screening), fast analysis is required for in-process testing (e.g., reaction completion) to allow processing to continue and maintain product quality, as continuing the reaction may generate impurities (e.g., lower yield and potentially product quality) with minimal benefit of converting reactant to product.
This presentation will highlight some examples of how new column technology such as fused-core particle columns has been used to meet the needs of the process chemistry environment.

Highlights:

  • An overview of the chromatographic demands within the process chemistry environment will be given
  • Examples of how fused-core column technology was used to meet the complex needs of the pharmaceutical industry using conventional instrumentation will be presented
  • The utility of the new, smaller (e.g. 2 µm) fused-core particle columns was explored with higher pressure instrumentation.


Who Should Attend

  • Method developers and QA/QC analysts within the pharma industry
  • Scientists interested in challenges with Fast HPLC and UHPLC

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