December 12th 2024
In this article, we review some key considerations for chromatographic technique selection and method development across the full drug process—from early-stage active pharmaceutical ingredient (API) synthesis to routine commercial release activities.
Pittcon: A Platform for Scientific Innovation Part I: Years 1950-1980
November 30th 2006Since the first Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy was held in 1950, Pittcon, as it is called today, has become a key meeting place where renowned scientists present their pioneering research and developers showcase the latest instruments that make many of those research scientific breakthroughs possible. This two-part article series will present a historical perspective on just a few of the significant scientific advancements that were discussed and demonstrated at Pittcon over the years. Part I will focus on new instruments and techniques that were presented at Pittcon from 1950 to 1980, and Part II will discuss a few of the many notable scientists and their discoveries that have been enabled by advances in mass spectrometry, capillary electrophoresis, and other instrumental techniques since 1980.
System Suitability and Validation for Chiral Purity Assays of Drug Substances
November 1st 2006Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This article describes a simple and practical approach to setting up system suitability and validation for chiral purity assays.
Market Profile: The Global Laboratory Life Science and Analytical Instrument Industry
November 1st 2006The laboratory life science and analytical instrument industry is comprised of a large, diverse group of organizations that manufacture and distribute their products worldwide. However, overall industry sales are concentrated among a small set of companies. Approximately 950 firms are included in the industry, but only about 100 companies have sales above $50 million.
Market Profile: Dissolution Testing
October 1st 2006Dissolution testing is a mandatory test for the physical evaluation of solid dosage forms such as capsules, tablets, ointments, and creams. The most basic form of testing measures the rate of dissolution or solubility of a drug tablet. Dissolution testing also can be used in ADME and bioavailability studies, release rates of a drug substance under different conditions, as well as provide information as to the efficacy of in-vivo performance.
2D Polymer LC as a High-Speed, High-Throughout Application
October 1st 20062D polymer liquid chromatography is a powerful tool for the deformulation of complex samples; however, it is considered to be very specialized and time-consuming. This article shows how recent hardware and software improvements have led to the technique becoming a method for routine analysis.
What's Happening to My Column?
September 1st 2006John Dolan addresses two column-related problems reported by readers - the first deals with a column that takes several injections to "settle down" for each batch of samples while the second problem relates to short column life due to early fouling of the column.
Gradient Performance Problems — A Case Study
September 1st 2006The gradient linearity and step tests are two of the most useful performance tests that can be made for a liquid chromatography (LC) system. These check the linearity of gradient generation and the accuracy of mobile phase proportioning. These tests, and examples of problems detected as a result of these tests, have been the subject of at least seven "LC Troubleshooting" columns over the last 18 years.1–7 We strongly recommend that every LC system undergo these tests at least on an annual basis, and preferably semiannually. When a new and different example of a problem detected by these tests is discovered, it is hard to bypass the opportunity to share it with our readers. So this month, you get yet another example of how an LC system can fail.
Market Profile: Fast Liquid Chromatography
September 1st 2006The market for high performance liquid chromatography (HPLC) continues to be one of the most dynamic markets of the analytical instruments industry. A few years ago, the HPLC market began showing signs of maturity with little product innovation and slower growth rates. Although innovations in mass spectrometry (MS) helped to fuel growth, HPLC was an afterthought and considered to be a mere inlet to MS. However, the recent development of fast liquid chromatography (LC) systems is energizing the HPLC market.