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 Water containing soluble impurities RIEFING USP 37 and Drug Products , and proposing a new chapter, 476 Organic Impurities in Drug Substances and Drug Products , which addresses organic impurities testing for articles with monographs 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 . James . Lazarcik. . 1, 2. , Jack . Dibb. . 1, 2. , Cameron Wake. . 1, 2. , . Alden Adolph. 3. 1 . Department of Earth Science , University of New Hampshire, Durham, NH, USA. 2. Institute for the Study of Earth, Oceans and Space, University of New Hampshire, Durham, NH, USA. recrystallisation. . . Step 1. Dissolve the impure. Crystals. Just enough hot water. to do the job. Step 2. Hot filtration . with suction. Takes out non-soluble . impurities. Step 3. Crystals allowed . 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. 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 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. 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?. 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.. 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.. Scientific™ Orbitrap Exploris™ . 120 MS. Hao Yang, Ph.D.. Sr. Application Scientist. Biopharma and Pharma Vertical Marketing. Application: Nitrosamine impurities analysis. 2. Liquid chromatography high resolution mass spectrometry (LC-HRMS) method for NAs detection and quantitation.