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A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [ 3 ] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application ) but not to paper submissions by electronic methods (i.e., faxes ).
Gas chromatography (GC) is a common type of chromatography used in analytical chemistry for separating and analyzing compounds that can be vaporized without decomposition. Typical uses of GC include testing the purity of a particular substance, or separating the different components of a mixture. [ 1 ]
The EPA's Good Laboratory Practice Standards (GLPS) compliance monitoring program guarantees the accuracy and reliability of test data submitted to the Agency to support pesticide product registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), section 5 of the Toxic Substances Control Act (TSCA), and in accordance ...
In NMR spectroscopy, e.g. of the nuclei 1 H, 13 C and 29 Si, frequencies depend on the magnetic field, which is not the same across all experiments. Therefore, frequencies are reported as relative differences to tetramethylsilane (TMS), an internal standard that George Tiers proposed in 1958 and that the International Union of Pure and Applied Chemistry has since endorsed.
As part of the post-September 11 drive towards increased capability in homeland security and public health preparedness, traditional GC–MS units with transmission quadrupole mass spectrometers, as well as those with cylindrical ion trap (CIT-MS) and toroidal ion trap (T-ITMS) mass spectrometers have been modified for field portability and ...
Pyrolysis GC/MS chromatogram of mahogany wood analyzed with OpenChrom. Pyrolysis–gas chromatography–mass spectrometry is a method of chemical analysis in which the sample is heated to decomposition to produce smaller molecules that are separated by gas chromatography and detected using mass spectrometry. [1] [2]
Specifically how the ions are produced is not necessarily understood, but the response of the detector is determined by the number of carbon atoms (ions) hitting the detector per unit time. This makes the detector sensitive to the mass rather than the concentration, which is useful because the response of the detector is not greatly affected by ...
Atmospheric pressure chemical ionization chamber cross section. Atmospheric pressure chemical ionization (APCI) is an ionization method used in mass spectrometry which utilizes gas-phase ion-molecule reactions at atmospheric pressure (10 5 Pa), [1] [2] commonly coupled with high-performance liquid chromatography (HPLC). [3]