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Pharmaceutical Preparations for Clinical Studies
It is known that the pharmacovigilance of a pharmaceutical preparation and the identification of drug products need to be taken out of the realm guesswork a pharmacist to an extent. Therefore, as of March 2010, a set guidelines was developed by the Joint Technical Committee for Drug Interactions (JTCDI, 2010) the proper identification of pharmaceutical preparations, especially in the clinical environment.
The JTCDI has given clear guidelines to all authors regarding appropriate identification, handling, and distribution of these medicinal products. Such use in clinical studies should be explicitly noted. Such identification of the product may be performed by using the standard methods outlined in this document as well many of the following procedures described in JTCDI.
The identification of pharmaceutical preparations should be based on the following procedure:
(1) The drug product must be identified by the appropriate International Union of Pharmacopoeia (IUPAC) chemical name[i, ii, iii] or standard name using a method established by the Joint Technical Committee, or a method of identification recommended by the Joint Technical Committee. identity of a particular drug substance may be determined as follows:
1. by direct visual inspection[iv]; or
2. by chemical analysis of microstructure (for example, gas chromatography–mass spectrometry (GC-MS)) or crystallographic analysis (for example, by scanning nuclear magnetic resonance (SNR) spectroscopy).
The description of each method should be listed in Appendix A, Figure A-4 and A-5, available as a link below:
Identification of Pharmaceutical Preparations by Direct Visual Inspection[i, ii, iii] or Standard Method of Identification(s) (available as a link below):
Identification of Pharmaceutical Preparations by Chemical Analysis (available as a link below):
Identification of Pharmaceutical Preparations by Gas Chromatography-Mass Spectrometry (available as a link below):
The procedures outlined above generally include identification of the following three chemical parameters when present in the same concentration: total amino canada pharmacy online coupon code acid, tryptic peptide, and total piperidine. When all three parameters are present, a four parameter method is specified.
An additional two procedures were created based on the JTCDI's protocol for chemical analyses identification of pharmaceutical products, namely the "CAS-based method for identification of natural products (a single residue or a mixture of residues), and the "GC-MS system for detection