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Brazilian Pharmacopoeia Brazilian Health Surveillance Agency Brazilian Pharmacopoeia Volume 1 5th edition Brasilia 2010 This translation does not replace the portuguese version. Copyright © 2010 Agência Nacional de Vigilância Sanitária e Fundação Oswaldo Cruz/Editora All rights reserved. The partial or total reproduction of this work is allowed, provided that the source is acknowledged. 5th edition President of the Republic President Paulo Gadelha Luiz Inácio Lula da Silva Vice President of Education, Information, and Com- Minister of Health munication José Gomes Temporão Maria do Carmo Leal Chairman Dirceu Raposo de Mello Deputy Director-President Pedro Ivo Sebba Ramalho Director Directors Maria do Carmo Leal Dirceu Aparecido Brás Barbano José Agenor Álvares da Silva Executive Editor Maria Cecília Martins Brito João Carlos Canossa Mendes Deputy Directors Science Editors Luiz Roberto da Silva Klassmann Nísia Trindade Lima e Ricardo Ventura Santos Neilton Araujo de Oliveira Luiz Armando Erthal Editorial Board Ana Lúcia Teles Rabello Chief of Staff Armando de Oliveira Schubach Iliana Alves Canoff Carlos E. A. Coimbra Jr. Gerson Oliveira Penna Gilberto Hochman Drafting and editing Joseli Lannes Vieira BRAZILIAN SANITARY SURVEILLANCE AGENCY Lígia Vieira da Silva SIA Trecho 5, Área Especial 57, Lote 200 Maria Cecília de Souza Minayo 71205-050, Brasília – DF Tel.: (61.3462-6000 Home page: www.anvisa.gov.br Brasil. Farmacopeia Brasileira, volume 1 / Agência Nacional de Vigilância Sanitária. Brasília: Anvisa, 2010. 548p., 1v/il. 1. Substâncias farmacêuticas químicas, vegetais e biológicas. 2. Medicamentos e correlatos. 3. Especificações e méto- dos de análise. I Título. ISBN 978-85-88233-40-9 This translation does not replace the portuguese version. RESOLUTION OF THE COLLEGIATE BOARD OF OFFICERS – RDC No. 49, NOVEMBER 23RD, 2010 It approves Brazilian Pharmacopoeia, 5th edition and provides further remedies. The Collegiate Board of Officers of the Brazilian Health Surveillance Agency, by using their attributions conferred by item IV of the art. 11 of the Regulation approved by Decree no. 3.029, April 16th, 1999, and in view of the provision in item II and paragraphs one and three of art. 53 of the Internal Regulations approved under Attachment I of the Ordinance No. 354 of ANVISA, August 11th, 2006, republished on the Official Gazette of August 21st, 2006 and what further appears in art. 7, item XIX of Law no. 9.782, January 26th, 1999, at a meeting held on November 11th, 2010, adopts the following Resolution of the Collegiate Board of Officers and I, CEO, determine its publication: Art. 1 It is hereby approved the Brazilian Pharmacopoeia, 5th edition, comprised of Volume 1 – General Methods and texts and Volume 2 - Monographs. Art. 2 The pharmaceutical inputs, the medicines and other products subject to health surveillance must fulfill the standards and specifications established in the Brazilian Pharmacopoeia. Sole paragraph. In the absence of the official monograph on raw material, pharmaceutical forms, correlates and general methods in the fifth edition of the Brazilian Pharmacopoeia, for the control of pharmaceutical inputs and products, the adoption of the latest edition of the official monograph, and foreign pharmaceutical codes in the manner provided in specific standards will be admitted. Art. 3 Printing, distributing, reproducing or selling the Brazilian Pharmacopoeia, 5th edition, with no previous and express consent from ANVISA is forbidden. Sole paragraph. Without prejudice of the provision in the caput of this article, ANVISA will make available, for free, on its website, the copy of the fifth edition and its updates. Art. 4 Fundação Oswaldo Cruz, by means of Editora Fiocruz, is authorized to market the copies of the fifth edition of the Brazilian Pharmacopoeia. Art. 5 All the monographs and general methods from previous editions of the Brazilian Pharmacopoeia are revoked. Art. 6 This Resolution will be in effect ninety (90) days after its publication Brasília, November 24, 2010 DIRCEU RAPOSO DE MELLO CEO of the Brazilian Health Surveillance Agency Published in the Daily Official Gazette No. 224, November 24, 2010 This translation does not replace the portuguese version. SUMMARY Volume 1 1 PREFACE ______________________________________________________________________________ 7 2 HISTORY ______________________________________________________________________________ 13 3 BRAZILIAN PHARMACOPOEIA _________________________________________________________ 21 4 GENERAL PROVISIONS _________________________________________________________________ 39 5 GENERAL METHODS ___________________________________________________________________ 59 5.1 general METHODS APPLIED to DRUGS _________________________________________________ 59 5.2 PHYSICAL AND PHYSICOCHEMICAL METHODS ___________________________________________ 81 5.3 CHEMICAL METHODS __________________________________________________________________ 162 5.4 METHODS OF PHARMACOGNOSY ________________________________________________________ 192 5.5 METHODS BIOLOGICAL, BIOLOGICAL AND MICROBIOLOGICAL TESTS ______________________ 207 5.6 METHODS IMUNOQUÍMICOS _____________________________________________________________ 278 5.7 PHYSICAL METHODS APPLIED TO MATERIALS AND SURGICAL HOSPITAL ___________________ 279 6.1 GLASS CONTAINERS ____________________________________________________________________ 285 6 CONTAINERS FOR MEDICINES AND CORRELATES ______________________________________ 285 6.2 PLASTIC CONTAINERS __________________________________________________________________ 288 7 PREPARATION OF STERILE CLEANROOM COVERALL PRODUCTS________________________ 321 7.1 ESTERILIZAÇÃO AND STERILITY ASSURANCE ____________________________________________ 321 7.2 BIOLOGICAL INDICATORS _______________________________________________________________ 326 7.3 PROCESS ASSÉPTICO ____________________________________________________________________ 329 7.4 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS __________________________ 330 7.5 PROCEDURES FOR RELEASE _____________________________________________________________ 336 8 STATISTICAL PROCEDURES APPLICABLE TO BIOLOGICAL TESTS _______________________ 338 8.1 GLOSSARY OF SYMBOLS ________________________________________________________________ 338 8.2 SUBMISSIONS __________________________________________________________________________ 339 8.3 ATYPICAL VALUES ______________________________________________________________________ 340 8.6 MOVABLE MEDIUM _____________________________________________________________________ 346 8.7 TESTS INDIRECT “ALL OR NOTHING” _____________________________________________________ 347 8.8 COMBINATION OF ESTIMATES OF POWER _________________________________________________ 347 8.9 TABLES STATISTICS _____________________________________________________________________ 349 8.10 EXAMPLES OF CALCULATING STATISTICAL TESTS APPLIED IN BIOLOGICAL ________________ 359 This translation does not replace the portuguese version. 9 RADIOPHARMACEUTICALS ____________________________________________________________ 373 10 PHARMACEUTICAL EQUIVALENCE AND BIOEQUIVALÊNCIA MEDICINES ________________ 387 11 WATER FOR PHARMACEUTICAL USE ___________________________________________________ 391 12 CHEMICAL SUBSTANCES REFERENCE __________________________________________________ 399 13 COLORING SUBSTANCES _______________________________________________________________ 401 14 REAGENTS ____________________________________________________________________________ 413 14.1 INDICATORS AND INDICATOR SOLUTIONS ________________________________________________ 413 14.2 REAGENTS AND REAGENT SOLUTIONS ___________________________________________________ 421 14.3 REMEDIES VOLUMÉTRICAS _____________________________________________________________ 500 14.4 BUFFERS _______________________________________________________________________________ 505 ANNEX A – PERIODIC TABLE OF ELEMENTS – CHEMICAL NAMES, SYMBOLS AND PASTA ATÔMICAS 511 ANNEX B – SYSTEM UNITS INTERNATIONAL (SI) USED IN PHARMACOPOEIA AND THE EQUIVALENCES WITH OTHER UNITS __________________________________________________________________________ 517 ANNEX C – Solvents FOR chromatography _______________________________________________ 53 ANNEX D – Alcoholometry ________________________________________________________________ 525 Volume 2 MONOGRAPHS This translation does not replace the portuguese version. This translation does not replace the portuguese version. Brazilian Pharmacopoeia, 5th edition 7 1a 1 PREFACE To preface such a significant work of a national thesis, master’s degree dissertation and specialization pharmacopoeia is not an easy task. When presenting a monographs. work, in which you are involved in a whole constructive process, you must take care to issue an opinion as exempt The scientific productions from the fifth edition took the as highly possible. Brazilian Pharmacopoeia 5 into a high technical-scientific degree with acknowledgement of international congeners. However, it is a huge pride to make it external, on behalf of a Commission and several Committees, the final All of this work was accomplished mainly due to the impressions of a technical and scientific work, to be structure constructed by the Permanent Commission for instrument for public health actions intended to protect the Review of the Brazilian Pharmacopoeia, responsible the population of your country by means of health risk for the fourth edition, which has the merit of having prevention. You cannot be negligent to the political force established
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