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The International Pharmacopoeia Fourth Edition - Pharmacopoea Internationalis Editio... Pagina 1 de 2 Methods of Analysis: 5. Pharmaceutical technical procedures: 5.7 Visual inspection of particulate matter in injectable preparations Particulate contamination of injections and parenteral infusions consists of extraneous, mobile, undissolved particles unintentionally present in the solutions. Disregard any gas bubbles. ‘The types of preparation for which compliance with this test is required are stated in the individual monograph. ‘This test provides a simple method for the detection of visible particles. It is performed in accordance with the provisions of Good Manufacturing Practices. The test is not intended for use by @ manufacturer for batch release purposes. To ensure that a product will meet pharmacopoeial specifications with respect to visible particulate matter, If and when tested, manufacturers should carry out a 100% inspection and rejection of unsatisfactory items prior to release or use other appropriate means. 7 Aajustable lamphoider Non-glare white panel Non-glare white pane! WHO 98430 jure 5. Apparatus for visible particles Reproduced with the permission of the European Pharmacopoeia Commission, European Directorate for the Quality of Medicines, Council of Europe. Subvisible particles and the nature of the particles are not identified by this method. Apparatus" This method was developed by WHO in collaboration with Group 12 of the European Pharmacopoeia Commission, ‘The apparatus (Fig. 5) consists of a viewing station comprising ~ a matt black panel of appropriate size held in a vertical position; - a non-glare white pane! of appropriate size held in a vertical position next to the black panel; - an adjustable lampholder fitted with a shaded, white-light source and with a light diffuser (a viewing illuminator containing two 13-W fluorescent tubes, each 525 mm in length is suitable). The intensity of illumination at the viewing point is maintained between 2000 lux and 3750 lux for clear glass ampoules. Higher values are preferable for coloured glass and plastic containers, The International Pharmacopoeia Fourth Edition - Pharmacopoea Internationals Editio ... Pagina 2 de 2 Recommended procedure Gently swirl or invert each individual container, making sure that no air bubbles are introduced, and ‘observe for about 5 seconds in front of the white panel. Repeat the pracedure in front of the black panel. Record the presence of any particles. Repeat the procedure for a further 19 containers. ‘The preparation fails the test if one or more particles are found in more than one container. When the test is applied to reconstituted solutions from powder for injections, the test fails if particles are found in more than two containers. WHO Pharmacopoeia Library Pagina i de 2 (LIB The International Pharmacopoeia Fourth Edition - Pharmacopoea Internationalis Editio Quarta - Second Su 9 Preface History 1) Acknowledgements General Notices Appendices to the General Notices = Monographs % (Pharmaceutical substances = 3 Dosage forms = [3 General monographs 5 Specific monographs # 5 Radiopharmaceuticals, 3 Methods of Analysis 1. Physical and Physicochemical Methods [} 1.4 Measurement of mass 55 1.2 Determination of melting temperature, melting range, congealing point, boiling point, and boil 51.3 Determination of mass density, relative density and weight per miliitre 5 1.4 Determination of optical rotation and specific rotation } 1.5 Determination of refractive index ) 1.6 Spectrophotometry in the visible and ultraviolet regions 3 1.7 Spectrophotometry in the infrared region 5) 1.8 Atomic spectrometry: emission and absorption 1.9 Fluorescence spectrophotometry 1.10 Turbidimetry and nephelometry 3 1.11 Colour of liquids ") 1.12 Powder fineness and sieves 5} 1.13 Determination of pH 1.14 Chromatography J 1.15 Electrophoresis ) 1.16 Phase solubility analysis 52. Chemical methods 5 3. Biological methods 5) 4. Methods for materials of plant origin = 5. Pharmaceutical technical procedures Introduction |.) S.l Uniformity of content for single-dose preparations 1) 5.2 Uniformity of mass for single-dose preparations 2 5.3 Disintegration test for tablets and capsules 5.4 Disintegration test for suppositories ) 5.5 Dissolution test for solid oral dosage forms 5.6 Test for extractable volume for parenteral preparations ULL } 5.8 Methods of sterilization #