Stability Indicating Assay For Mirtazapine As Per ICH By UPLC & HPL

ISBN-13: 9783659796715 / Angielski / Miękka / 2015 / 84 str.

Patel Kuldeep Singh

Opis

UPLC - Ultra performance Liquid Chromatography, is highly sophisticated advanced instrument introduced in the Pharma Industries. Here we have covered the advancements that have been made in this instrument by giving more stress on its columns. It comprises of five types of columns each designed for specific samples. This book also covers the specification of the columns, along with their instrumentation. Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product.

O autorze

Kuldeep Singh Patel is currently working as an Associate Professor in NRI INSTITUTE OF PHARMACEUTICAL SCIENCES Bhopal(India).He completed his B.Pharm from Barkatullah university,Bhopal(India)in 2007 and PG from RGPV,Bhopal(India) in 2009.He has published more than 10 International & 11 National Research papers.He has 5 years of teaching experience.