Title: GC Method developments and solutions

Biography:

Dr. Rahul Hajare is affiliated to National AIDS Research Institute Pune, India. Dr.Hajare has won World Academic Championship-2017 in Pharmacy (Antiretroviral Therapy) and certified as Fellow, Directorate of Pharmacy, IASR (Lifetime Membership). He is a formerly post-doctoral fellow of Indian Council of Medical Research New Delhi. He has M.Pharm, Masters in Quality Assurance from Nagpur University. He has completed his PhD at the age of 32 years from Vinayaka Missions University.

Abstract

Acceptance of high quality product is first choice of vendors and it must be in reasonable cost, pharmaceutical impurity could not be a facility in pharmaceutical product, it has been compromising the effect of drugs. Due to ever –increasing failure rates, high cost, unsatisfactory safety profile and limited efficacy associated with production of drug key intermediate for active pharmaceutical ingredient and market cost differ by International Pharmacopeial standard. We invented economical new technology for estimation of residual solvents by ultra-capillary GC methods.The synthesis of an active pharmaceutical ingredient (API) normally consists of several synthetic steps. Process-related impurities can be formed at any step and could ultimately appear in the final drug substance, particularly in the scale-up drug candidates. Impurities must be controlled because of their potential toxicity. Impurity control is a continuing concern of regulatory agencies and the pharmaceutical industry. The use of specialized holding technology, time management and detection methods. Researchers have reported that OVIs with these experiences are more difficult to treat; many do not access treatment and those who do, frequently do not stay because of difficulty maintaining helping solvents coordination. The purpose of this study is to describe the experience of seeking help for residual solvents dependency by manufactures with a history of OVIs in the context in which it occurs. Methodology & Technical Orientation: GC-2010 plus ultra-trace capillary column applications chemicals and reagents water, methanol, ethanol, isopropyl alcohol, methylene chloride, chloroform, 1, 4-dioxane. Solvents were authorized from sigma-aldrich Company (MO, USA).