New HPLC and UHPLC Assay Methods for TC-HCl and 4-EATC Impurity in TC Drug Products

6 Mar 2012

Read this study which shows how HPLC and UHPLC methods can be used to assay TC and EATC in a TC-HCl capsule. The results from both methods meet or exceed the criteria in the appropriate USP monographs. Both methods are faster and show higher resolution than the current methods. They also generate less waste and use less hazardous organic solvents. These methods may be applicable to other TC-HCl-containing drug products.

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.TetracyclineAntibioticsAntibiotics are substances that kill or inhibit the growth of microorganisms, such as bacteria and fungi. They are essential in the treatment of infections and in preventing disease spread. Explore antibiotics research and diagnostic tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.