Progress in medical and pharmaceutical technology is a key driver to increase people’s life expectancy. Furthermore, research leading to advanced diagnostics, treatments and therapies assist to fight and cure illnesses. Drugs help to overcome diseases or in case of chronic or incurable cases, they support to continuously take part in social life.
In drugs, side effects from interfering substances and contaminations are undesirable. This is why it is important to use the purest possible substances and purified equipment and materials in the production of drugs. In the production of medicines, methods and rules for the manufacture, storage, quality and testing of drugs are standardized and defined in Pharmacopoeias.
Analysis of Impurities in Sartan-Type Bulk Drug Substances
In July 2018, the American Food and Drug Administration (FDA) announced that the carcinogenic impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) had been detected in Valsartan bulk drug substances manufactured by Chinese manufacturers. Subsequently, a worldwide recall was issued of pharmaceutical products that use Valsartan bulk drug substances. Valsartan is used in the treatment of high blood pressure and congestive heart failure.
The FDA has announced analysis methods using gas chromatography mass spectrometry (GC-MS and GC-MS/MS) as detection methods for NDMA and NDEA, while the European Directorate for the Quality of Medicines (EDQM) has announced analysis methods using liquid chromatography mass spectrometry (LC-MS/MS) and GC/MS as reference information.
Broad variety of analytical solutions
From Drug Discovery to Quality Control, Shimadzu’s wide range of solutions supports the pharmaceutical industry through chromatography (GC and HPLC), spectroscopy (UV-Vis, FTIR, AAS, ICP), mass spectrometry (LC-MS, GC-MS), sum parameter (TOC), and MALDI-TOF systems including MS imaging. Shimadzu combines a long history in the market with a comprehensive product portfolio and expertise in regulatory compliance, making the company the perfect partner for the pharmaceutical industry.
Shimadzu’s systems cover applications in
- life science research for pharmaceutical (genomics, proteomics, metabolomics, glycomics)
- drug discovery (biomarker discovery, screening and drug synthesis)
- drug development (pre-clinical development, toxicology, pharmacology, formulation, process development)
- drug metabolism (ADME, DMPK)
- manufacturing and QA/QC (process for production, quality control and assurance)
- biopharmaceutical (protein characterization, impurity analysis for quality assurance)
- herbal medicine/natural product.
Cannabis Testing Solutions
Portland, Oregon USA
August, 28-30 at the Oregon Convention Center
Webinar by Scott Kuzdzal of Shimadzu Scientific Instruments (SSI).
Thursday, January 19, 2017
12:00 - 01:00 p.m. EST
U.S. Medical Marijuana Empowers A Cannabis Laboratory Revolution
Scott Kuzdzal, Ph.D., William Lipps, Shimadzu Scientific Instruments, USA
Published in: Separation 02/15
Legalized cannabis is an exploding market that offers exciting opportunities – and challenges – for analytical scientists. Here, we offer an overview of the fast-emerging field of cannabinomics and the analytical methods being employed.
Scott Kuzdzal and William Lipps, pages 24-32
Published in: The Analytical Scientist, September 2015, #32
Forensics/Toxicology and more...
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- Forensics: Determination of opiates, amphetamines and cocaine in whole blood, plasma and urine by UHPLC-MS/MS using QuECheRS sample preparation
- Herbal Remedies: A Closer Look at Cannabis Testing
News & Hot Topics
FDA Issues Guidance for Industry on ANDAs: Impurities in Drug Products