PPT-1 1 3.2.S.3.2 Impurities,

Malaysia 29 September 2011 Impurities Dr Antony Fake WHO Prequalification Team Medicines Introduction This presentation is made with reference to the preparation of the API This is because the API is the source of the majority of impurities. Gottlieb Vadim Kotlyar and Abraham Nudelman Department of Chemistry BarIlan University RamatGan 52900 Israel Received June 27 1997 In the course of the routine use of NMR as an aid for organicchemistryadaytodayproblemistheidentifica tion of signals ARMONISED RIPARTITE UIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current Step 4 version dated 2 June 2006 This Guideline has been developed by tation by the regulatory parties, in accordance w Malaysia, 29 September 2011. Active Pharmaceutical Ingredient (API). Prequalification. Dr Antony . Fake. WHO Prequalification . Team - Medicines. API – Active Pharmaceutical Ingredient (. drug substance. Joshua J. Coon. U. Wisconsin-Madison. Isobaric Tagging. Ross,PL. . et al. . MCP. . 2004. iTRAQ. Structure. Available Reagents. Phosphorylation. site on LIN28. Contemporary proteomics. Introduction of internal standard. . Bujji Kanchi. Main Objective works for stability. Before performing stability studies, a stability indicating method is necessary so that any possible degradants generated during storage conditions (such as 5°C, 25°C/60%RH and 40°C/75%RH) can be separated, detected, and . and. Prevent Decay. Ye are the salt of the earth: but if the salt have lost his . savour. , wherewith shall it be salted? it is thenceforth good for nothing, but to be cast out, and to be trodden under foot of men. BP Schools Link. Looking for Chemicals which are hidden . BP Schools Link – . Creative Chromatography. 8. In some products the chemicals we want to measure can be hidden / masked by other bigger molecules. Two form of charge carrier transport. . (1) Drift (due to E-field). . (2) Diffusion (due to density gradient). for two types of charge carriers. . (a) n-type (electrons). . (b) p-type (holes). Drift current – due to E-field. and . poisons. Rates of Reaction. Catalytic Converters. Exhaust fumes contain. CO – . due . to incomplete combustion of hydrocarbons. NO & NO. 2. – . N. 2. . in air is oxidised at high temperatures. Proposing a Procedure. Library. Primary literature. SciFinder. Scholar. Secondary Literature. Organic Syntheses. Fieser. Comprehensive Organic Transformations. Case Study: Benzoic Acid. Literature: Try a Grignard Reaction. Water . is one of the most important substances on earth. All plants and animals must have water to survive. If there was no water there would be no life on earth.. Apart from drinking it to survive, people have many other uses for water. These include. ALONG WITH . H/D. EXCHANGE TO CHARACTERIZE . ANTIPLATELET DRUG DEGRADATION PATHWAYS.. A case report. .. B. ernard Do*, . Fatma . Amrani. , . Philippe-Henri . Secrétanand. . Najet. . Yagoubi. *Hospital Pharmacist . By . S . S. D BHAVANI RAJA. ASSISTANT PROFESSOR . DEPARTMENT. OF . PHARMACEUTICAL CHEMISTRY. Sources of Impurities. Department of Pharmaceutical Chemistry. Sources of Impurities. Impurity:-. Any substance coexisting with the original drug such as starting material or intermediate or that is formed due to any side reactions.. Cristian SAMPAOLESI. Certification of Substances Department (DCEP). EDQM, Council of Europe. 22 November 2019, Pavia - Italy. Deficiencies: How to avoid them ?. Reference documents. PA/PH/CEP (04) . 1, 6R (December 2018).