Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body of humans or other animals. APIs include substances manufactured by processes such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources; or (5) any combination of these processes.
See also: Active Ingredient, Pharmaceutical Intermediate, Reference StandardAny component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to effect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.
See also: API, Pharmaceutical IntermediateUnique number assigned to a specific chemical (identified by its chemical name) by the American Chemical Society and indexed in Chemical Abstracts published by Chemical Abstracts Service in the US. CAS numbers are used widely for accurate identification of materials and quick retrieval of their chemical and safety information.
See also: IUPACAn expression which states the number and type of atoms present in a molecule of a substance.
See also: IUPACA traditional system of medical treatment based on the principles of Yin and Yang, involving suchtreatments as acupuncture and the use of a range of drugs derived from animal and vegetable sources
See also: Herb, Whole HerbAn authenticated document, issued by an appropriate authority, that certifies the quality and purity of pharmaceuticals, and animal and plant products being exported.
See also: MSDSA flowering plant whose stem does not produce woody tissue and generally dies back at the end of each growing season. Both grasses and forbs are herbs. Herb also means such a plant when valued for its medicinal properties, flavor, scent, or the like.
See also: Herbal Extract, Standard Herbal Extract, Chinese MedicineA substance, either pure chemicals or mixture, taken from the herbs using the whole plant or some organs like bark, stalk, flower, husk, seed, etc. and used especially in food or medicine.
See also: Herb, Standard Herbal Extract, Chinese MedicineHigh-performance liquid chromatography (HPLC) is a form of liquid chromatography used to separate compounds that are dissolved in solution. HPLC instruments consist of a reservoir of mobile phase, a pump, an injector, a separation column, and a detector. Compounds are separated by injecting a plug of the sample mixture onto the column. The different components in the mixture pass through the column at different rates due to differences in their partitioning behavior between the mobile liquid phase and the stationary phase. Solvents must be degassed to eliminate formation of bubbles. The pumps provide a steady high pressure with no pulsating, and can be programmed to vary the composition of the solvent during the course of the separation. Typical detectors rely on a change in refractive index, UV-VIS absorption, or fluorescence after excitation with a suitable wavelength.
See also: LC-MSThe part of the invisible spectrum that is contiguous to the red end of the visible spectrum and that comprises electromagnetic radiation of wavelengths from 800 nm to 1 mm.
See also: Infrared Spectroscopy, UltravioletAn instrumental technique used to identify substances—in particular the functional groups present in organic compounds by measuring their absorption of infrared radiation over a range of frequencies. The absorption pattern is then compared to the infrared spectra of known substances for identification.
See also: Infrared, Ultraviolet SpectroscopyA recognized authority for chemical standards of nomenclature, measurements, and atomic mass values.
See also: Chemical Formula, CAS No.The total weight including all mass weights of a molecule. Example: Water, or H2O, has a molecular weight of 18. Two from the two hydrogens (1 Ă— 2 = 2) plus 16 from the oxygen.
Formal document containing important information about the characteristics and actual or potential hazards of a substance. It identifies the manufacturer of the material (with name, address, phone, and fax number) and usually includes (1) chemical identity, (2) hazardous ingredients, (3) physical and chemical properties, (4) fire and explosion data, (5) reactivity data, (6) health hazards data, (7) exposure limits data, (8) precautions for safe storage and handling, (9) need for protective gear, and (10) spill control, cleanup, and disposal procedures. Mandated by the US Occupational Safety and Health Administration (OSHA), it is used also in many other countries in one form or the other. Called chemical safety data sheet (CSDS) in Europe.
See also: CoAA chemical substance produced by a living organism; - a term used commonly in reference to chemical substances found in nature that have distinctive pharmacological effects. Such a substance is considered a natural product even if it can be prepared by total synthesis.
See also: Natural Product Chemistry, Herbal ExtractThat branch of chemistry which deals with the isolation, identification, structure elucidation, and study of the chemical characteristics of chemical substances produced by living organisms.
See also: Natural Product, Herbal ExtractThe absorption of electromagnetic radiation of a specific frequency by an atomic nucleus that is placed in a strong magnetic field, used especially in spectroscopic studies of molecular structure and in medicine to measure rates of metabolism.
An organic compound that is formed in a stage between the parent substance and the final pharmaceutical compound. It is a "stepping stone" in the synthesis of the final product.
See also: API, Active IngredientA standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be compared.
See also: APIA standardized herbal extract is an herb extract that has one or more components present in a specific, guaranteed amount, usually expressed as a percentage. The intention behind the standardization of herbs is to guarantee that the consumer is getting a product in which the chemistry is consistent from batch to batch. This practice has developed out of the drug model of herbal medicine, in which modern scientists have attempted to identify the components of a plant that have definite pharmacological activity in the body.
See also: Whole Herb, Herbal Extract, Herb, Chinese MedicineThe range of invisible radiation wavelengths from about 4 nanometers, on the border of the x-ray region, to about 380 nanometers, just beyond the violet in the visible spectrum.
See also: Infrared, Ultraviolet SpectroscopyAn instrumental scanning method that analyzes the absorption of light within the UV spectrum. Many flavor chemicals absorb UV light at different wavelengths. Absorptivity is the function of the absorbance (signal strength) and the concentration of the sample in moles/liter. (Cell size is usually 1 cm.) Visible spectroscopy uses the visible color spectrum (ROY G BIV) or red orange yellow green blue indigo and violet. On the other side of red is infrared, and on the other side of violet is UV or ultraviolet.
See also: Ultraviolet, Infrared SpectroscopyWhole herbs are usually dried and encapsulated or processed and preserved in alcohol or another solvent. Whole herbs contain all of the constituents of the plant and have been used for hundreds of years by many cultures. In fact, modern medicine originated with the use of whole herbs. Although the effects of herbs have not always been formally and scientifically researched, whole herbs have a long track record validating their safety and efficacy.
See also: Standard Herbal Extract, Herbal Extract, Herb, Chinese MedicineLiquid chromatography-mass spectrometry. an analytical chemistry technique that combines the physical separation capabilities of liquid chromatography (or HPLC) with the mass analysis capabilities of mass spectrometry. There are a lot of mass analyzers that can be used in LC/MS. Single Quadrupole, Triple Quadrupole, Ion Trap, TOF (time of Flight) and Quadrupole-time of flight (Q-TOF). - See more at: http://www.selleckchem.com/glossary.html
See also: HPLCA compound that could potentially be converted to a new drug by optimizing its beneficial effects and minimizing its toxicity and side effects. Identifying lead compounds (typically by high-throughput screening) is the first step in the drug discovery process once a useful therapeutic target has been identified and validated through genomics and pharmacology. Typically, many potential compounds are screened (the primary screen) and numerous tight-binders (hits) are identified. These compounds are then taken through successive rounds of screening (secondary screens) of increasing stringency in order to determine their suitability for lead optimization.