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: Shiyan Jakirhusen Shaikh*, Shrinivas Mane, Sanjay K. Bais
Email: shaikh6may@gmail.com
College: Fabtech College of Pharmacy, Sangola, Maharashtra 3728-3741
USFDA, and ICH and other regulatory bodies are placing a strong emphasis on the detection of contaminants in pharmaceutical active ingredients (APIs) and purity standards that must be met. The process of acquiring and reviewing data to establish the biological safety of each impurity and, thus, its level of qualification the necessity and extent of medication impurity profiling in pharmaceutical research. To identify pollutants, a variety of chromatographic and spectroscopic methods can be applied either alone or in combination with other methods. Impurities can be found and characterized using a variety of techniques like TLC, HPLC, HPTLC, AAS, etc. The discipline of Profiling impurities has utilized conventional LC and HPLC. This method numerous uses might result from its sensitivity, affordability, ability to disentangle a variety of detectors and stationary phases. The most popular separating method is TLC among the several Planar Chromatographic Methods, for isolation of contaminants; as a result of its affordability and ease of use in comparison to HPLC. A popular method for isolating impurities is thin-layer chromatography (HPTLC), which has advanced throughout time. Headspace gas phase separation is a highly favored method for determining the presence of leftover solvents. Hyphenated approaches have revolutionized impurity profiling by enabling structural identification of impurities in addition to their separation.
impurities, Analytical method development, Spectrophotometry, Chromatography