Archives in Chemical Research Open Access

Pharmaceutical impurity analysis of raw materials and final product by using analytical techniques

Joint Event on 9^th Edition of International Conference on Chemistry Science and Technology & 11^th International Conference & Expo on Chromatography Techniques

April 22-24, 2019 Dublin, Ireland

Muhammad Jehangir

NovaMed Pharmaceuticals (Pvt) Ltd., Pakistan

Scientific Tracks Abstracts: Arch Chem Res

Abstract:

Isolation and identification of unknown components and impurities and the evaluation of pharmaceutical raw materials and finished products for impurities and degradation products is an essential part of the drug development and manufacturing testing process. Additionally, toxicological information must be obtained on any drug-related impurity that is present at a concentration of greater than 0.1% of the active pharmaceutical ingredient (API). In pharmaceutical QC and manufacturing, impurity analysis has traditionally been performed by HPLC with UV, PDA, or MS detection. As it is essential to detect and measure all the impurities in the sample, it is necessary to have a high resolution separation process. This usually involves long analysis times resulting in low throughput. As candidate, pharmaceutical compounds become more potent and are dosed at lower and lower levels, ever more sensitive assays are needed to detect and measure impurities. The low throughput of HPLC can become the rate-limiting step in product release testing or process evaluation. Since much of the process of impurity identification involves the coupling of LC to sophisticated MS, any reduction in analysis time will result in a more efficient use of these significant investments. Analytical technology advances such as UPLC and UPC offer significant improvements in throughput and sensitivity, with benefits to the process of product release and identification of drug-related impurities. The most characteristic feature of the development in the methodology of pharmaceutical and biomedical analysis during the past 25 years is that HPLC became undoubtedly the most important analytical method for identification and quantification of drugs, either in their active pharmaceutical ingredient or in their formulations during the process of their discovery, development and manufacturing.

Biography :

Muhammad Jehangir has 12 years of diversified experience in Quality Control, Quality Assurance, Registration Affairs, Product development and Pharmaceutical manufacturing, Process Planning, Method development, Method validation, Statistical Methodology, Process and Cleaning Validation, Equipment Validation, etc. He did certificate courses on cGMP, cGLP, Process Validation, CTD Documents, ISO 9001:2008, 13485-2003 and 14001-2004 have strong scientific, analytical, statistical, managerial and training skills. Currently, he is working as a Senior Manager Quality Control and validation for Novamed Pharmaceuticals. It is toll manufacturing oriented company, manufacturing of companies like Getz Pharma, ICI, SEARLE, Macter, Ray and for Sanofi-Aventis. He is also looking after the quality of novamed healthcare, the nutraceutical and cosmeceutical manufacturing plant.