FREQUENCY : QUARTERLY
PUBLISHER : ANANDI HEALCARE LLP,WASHIM-444505
CHIEF EDITOR : Dr. Prashant Sakharkar
COPYRIGHT : INTERNATIONAL JOURNAL OF PHARMACY AND HERBAL TECHNOLOGY
STARTING YEAR : 2023
SUBJECT : MEDICAL SCIENCES
LANGUAGE : ENGLISH
PUBLICATION FORMAT : ONLINE
PHONE NO : +91 9172954046
EMAIL ID : editorijpht@gmail.com
WEBSITE : www.ijprdjournal.com
ADDRESS : Near Kaleshwwar Mandir Shukrawar peth, Washim-444505 Maharashtra
Author Name: Priyanka S. Mali *, Savita D. Sonawane, Sanjay K. Bais
Email: priyamali2312@gmail.com
College: Fabtech College of Pharmacy, Sangola, Maharashtra 2922-2940
Different regulatory bodies, including the USFDA, ICH, and “Canadian Drug and Health Agency”, give special attention to on identifying impurities and ensuring that active APIs meet purity standards. The process of gathering and evaluating information that outlines each impurities biological safety is known as "qualification of the impurities." This method exposes the necessity and extent of “impurity profiling” of pharmaceuticals studies. Chromatographic and spectroscopic methods are used to identify impurities; these methods can be used alone or in combination. Impurity detection and characterization can be done in a number of ways employing methods like “HPLC, AAS, HPTLC, TLC”, etc. The disciplines of profiling impurities have made extensive use of conventional liquid chromatography, primarily HPLC; its variety of sensors, sensibility, stationary phases, and operational price effectiveness make it the industry standard. Effective separation has been attributed to the multifunctionality of its application. “Thin Layer Chromatography” is the most often utilized isolation method for impurity separation out of all the various types of planar chromatographic techniques since it is less expensive than HPLC and has a high degree of operational simplicity. An approach that is often utilized for impurity isolation is HPTLC, a variation of “Thin Layer Chromatography”. Among a most popular techniques for identifying residual solvents are headspace GC. Impurity profiling has been transformed by hyphenated techniques, which enable both solvent separation and structural identification of impurities. a combination of, “LC-NMR, LC-NMR-MS GC-MS and LC-MS” are the most popular hyphenated techniques for profiling drug impurities.
ICH guidelines, Impurities, Standard analytical methods, Spectroscopy, Chromatographic Methods, Isolation