PPT-1 1 3.2.S.3.2 Impurities,

Malaysia 29 September 2011 Active Pharmaceutical Ingredient API Prequalification Dr Antony Fake WHO Prequalification Team Medicines API Active Pharmaceutical Ingredient drug substance. 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 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 . 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.. ICH Topic Q3A (R) – Revised Guidelines in Oct-2006.. الشوائب في الأدوية الجديدة . Contents. 1. . Preamble . . 2. Classification of . Impurities . 3. Rationale for the Reporting and Control of Impurities . Dr. Christian Zeine, . Warsaw. , Nov 18, 2014. Science. . for a safer world. Topics . of. . today‘s. talk. Fundamental . guidelines. . from. ICH. Influence. . of. ICH . impurity. . guidelines. 4. -recuperation unit for the CSC of CMS. Conseil Européen pour la Recherche Nucléaire (CERN).. Fontys Hogescholen . Date: . 08 November 2010. Sander . Rouwette. Table of Contents. Introduction to CERN. 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. Is impurity greaterthan identification thresholda? Yes No No action Structure known human Yes identified? relevant risksb? No No Greater NoReduce than qualification safe level to not more than No 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. Water. Carbohydrates. Electrolytes. 6-8% concentration of carbohydrates and electrolytes. Did we prove that our mystery sports drink was “beneficial”?. What happened to the liquid in our mystery sports drink?. Properties of Metals. Worksheet .  Metals. ¾ of all known elements. Solid at room temp (NOT Mercury). Low IE = give up electrons. Metallic bonds. Delocalization. Malleable, ductile. Alkali Metals.