Chromatography Column
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Chromatography Column
A Chromatography column is a device used in chromatography for the separation of chemical compounds. A chromatography column contains the stationary phase, allowing the mobile phase to pass through it. Chromatography columns of different types are used in both gas and liquid chromatography. Materials * Liquid chromatography: Traditional chromatography columns were made of glass. Modern columns are mostly made of borosilicate glass, acrylic glass or stainless steel. To prevent the stationary phase from leaking out of the column interior a polymer, stainless steel or ceramic net is usually applied. Depending on the application material- and size-requirements may change. * Gas chromatography (GC): Older columns were made of glass or metal packed with particles of a solid stationary phase. More recently, narrower diameter (capillary) columns have been made using fused silica coated on the inside with a film of the stationary phase material. GC columns are typically very long to t ...
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Chromatography Column
A Chromatography column is a device used in chromatography for the separation of chemical compounds. A chromatography column contains the stationary phase, allowing the mobile phase to pass through it. Chromatography columns of different types are used in both gas and liquid chromatography. Materials * Liquid chromatography: Traditional chromatography columns were made of glass. Modern columns are mostly made of borosilicate glass, acrylic glass or stainless steel. To prevent the stationary phase from leaking out of the column interior a polymer, stainless steel or ceramic net is usually applied. Depending on the application material- and size-requirements may change. * Gas chromatography (GC): Older columns were made of glass or metal packed with particles of a solid stationary phase. More recently, narrower diameter (capillary) columns have been made using fused silica coated on the inside with a film of the stationary phase material. GC columns are typically very long to t ...
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Design Of Experiments
The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associated with experiments in which the design introduces conditions that directly affect the variation, but may also refer to the design of quasi-experiments, in which natural conditions that influence the variation are selected for observation. In its simplest form, an experiment aims at predicting the outcome by introducing a change of the preconditions, which is represented by one or more independent variables, also referred to as "input variables" or "predictor variables." The change in one or more independent variables is generally hypothesized to result in a change in one or more dependent variables, also referred to as "output variables" or "response variables." The experimental design may also identify control variables that must be h ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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Biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological ...
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Research And Development
Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existing ones. Research and development constitutes the first stage of development of a potential new service or the production process. R&D activities differ from institution to institution, with two primary models of an R&D department either staffed by engineers and tasked with directly developing new products, or staffed with industrial scientists and tasked with applied research in scientific or technological fields, which may facilitate future product development. R&D differs from the vast majority of corporate activities in that it is not intended to yield immediate profit, and generally carries greater risk and an uncertain return on investment. However R&D is crucial for acquiring larger shares of the market through the marketisation ...
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Validation (drug Manufacture)
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: *Equipment validation *Facilities validation *HVAC system validation *Cleaning ...
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Proof Of Concept
Proof of concept (POC or PoC), also known as proof of principle, is a realization of a certain method or idea in order to demonstrate its feasibility, or a demonstration in principle with the aim of verifying that some concept or theory has practical potential. A proof of concept is usually small and may or may not be complete. These collaborative trials aim to test feasibility of business concepts and proposals to solve business problems and accelerate business innovation goals. A proof of value (PoV) is sometimes used along proof of concept, and differs by focusing more on demonstrating the potential customers use case and value, and is usually less in-depth than a proof of concept. Usage history The term has been in use since 1967. In a 1969 hearing of the Committee on Science and Astronautics, Subcommittee on Advanced Research and Technology, ''proof of concept'' was defined as following: One definition of the term "proof of concept" was by Bruce Carsten in the context o ...
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Diameters
In geometry, a diameter of a circle is any straight line segment that passes through the center of the circle and whose endpoints lie on the circle. It can also be defined as the longest chord of the circle. Both definitions are also valid for the diameter of a sphere. In more modern usage, the length d of a diameter is also called the diameter. In this sense one speaks of diameter rather than diameter (which refers to the line segment itself), because all diameters of a circle or sphere have the same length, this being twice the radius r. :d = 2r \qquad\text\qquad r = \frac. For a convex shape in the plane, the diameter is defined to be the largest distance that can be formed between two opposite parallel lines tangent to its boundary, and the is often defined to be the smallest such distance. Both quantities can be calculated efficiently using rotating calipers. For a curve of constant width such as the Reuleaux triangle, the width and diameter are the same because all ...
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Chromatography
In chemical analysis, chromatography is a laboratory technique for the separation of a mixture into its components. The mixture is dissolved in a fluid solvent (gas or liquid) called the ''mobile phase'', which carries it through a system (a column, a capillary tube, a plate, or a sheet) on which a material called the ''stationary phase'' is fixed. Because the different constituents of the mixture tend to have different affinities for the stationary phase and are retained for different lengths of time depending on their interactions with its surface sites, the constituents travel at different apparent velocities in the mobile fluid, causing them to separate. The separation is based on the differential partitioning between the mobile and the stationary phases. Subtle differences in a compound's partition coefficient result in differential retention on the stationary phase and thus affect the separation. Chromatography may be preparative or analytical. The purpose of preparativ ...
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Stainless Steel
Stainless steel is an alloy of iron that is resistant to rusting and corrosion. It contains at least 11% chromium and may contain elements such as carbon, other nonmetals and metals to obtain other desired properties. Stainless steel's corrosion resistance, resistance to corrosion results from the chromium, which forms a Passivation (chemistry), passive film that can protect the material and self-healing material, self-heal in the presence of oxygen. The alloy's properties, such as luster and resistance to corrosion, are useful in many applications. Stainless steel can be rolled into Sheet metal, sheets, plates, bars, wire, and tubing. These can be used in cookware, cutlery, surgical instruments, major appliances, vehicles, construction material in large buildings, industrial equipment (e.g., in paper mills, chemical plants, water treatment), and storage tanks and tankers for chemicals and food products. The biological cleanability of stainless steel is superior to both alumi ...
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Acrylic Glass
Poly(methyl methacrylate) (PMMA) belongs to a group of materials called engineering plastics. It is a transparent thermoplastic. PMMA is also known as acrylic, acrylic glass, as well as by the trade names and brands Crylux, Plexiglas, Acrylite, Astariglas, Lucite, Perclax, and Perspex, among several others ( see below). This plastic is often used in sheet form as a lightweight or shatter-resistant alternative to glass. It can also be used as a casting resin, in inks and coatings, and for many other purposes. Although not a type of familiar silica-based glass, the substance, like many thermoplastics, is often technically classified as a type of glass, in that it is a non-crystalline vitreous substance—hence its occasional historic designation as ''acrylic glass''. Chemically, it is the synthetic polymer of methyl methacrylate. It was developed in 1928 in several different laboratories by many chemists, such as William Chalmers, Otto Röhm, and Walter Bauer, and first brought ...
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