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Pharmaceutical analysis From Metrohm

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Metrohm Applications for Pharma Sector

Text of Pharmaceutical analysis From Metrohm

  • 1. Pharmaceutical analysisQuality assurance of pharmaceuticals

2. 02 Metrohm... is the global market leader in titration is the only company to offer a complete range of ion analysis equipment titration, voltammetry and ion chromatography is a Swiss company and manufactures exclusively in Switzerland grants a 3-year instrument warranty and a 10-year warranty on chemical suppressors for ion chromatography provides you with unparalleled application expertise offers you more than 1300 applications free of charge supports you with expert service through local representatives and regional support centers is not listed on the stock exchange, but is owned by a foundation gives the interest of customers and employees priority over maximizing profit 3. Metrohm customized analysis for thepharmaceutical industryThe regulatory authorities set high standardsWith regard to the quality and safety of drugs, authori-You can count on our supportAs a leading manufacturer of instruments for chemical03ties worldwide set high standards for the pharmaceuticalanalysis, we are aware of these challenges. For this rea-industry. These are documented in pharmacopoeias in son, Metrohm offers you not only the latest instruments,the form of official collections of recognized pharmaceu- but complete solutions for very specific analytical issues.tical rules. As legal tools of consumer protection, theyYour Metrohm contacts are competent specialists, whoensure that drugs are used safely. It is only the measuring will develop customized applications and provide youand test procedures used within the framework of drug with professional support in all matters of regulatorytesting that identify a drug and determine whether it iscompliance.approved or not.Discover on the following pages what solutions MetrohmTo ensure these high quality and safety standards, reliable is able to offer the pharmaceutical sector in general andinstruments and methods are needed. you in particular, to ensure the quality and safety of yourproducts. Challenge us! 4. Chemical pharmaceutical analysis04 The history of pharmacy The search for remedies is as old as humanity itself. There Determination of active ingredients, excipients and impurities is evidence that the first advanced civilizations (China, Pharmaceutical analysis provides information on the India, Mesopotamia, Egypt) were already using drugs ofidentity, purity, content and stability of starting materials, plant, mineral and animal origin for medicinal purposes.excipients and active pharmaceutical ingredients (APIs). A Systematic descriptions of remedies have been handeddistinction is made between analysis of the pure active down to us from Greek antiquity (Hippocrates, Theo- ingredients used to cure, alleviate, prevent or identify ill- phrastus) and from the Roman Empire (Dioscorides, nesses and diseases (active ingredient analysis) and Galen). This knowledge was adopted by Arabian scholarsanalysis of medicinal preparations. The latter can exist in (e.g., Avicenna) and was developed further. It served for various forms (ointments, tinctures, pills, lotions, suppo- a long time as an important basis of medicine. It was not sitories, infusions, drops, etc.) and consists of the phar- until the 16th century that this began to detach itself maceutically active substance and at least one pharma- from the ancient models. A typical representative of theceutical excipient. Impurities usually stem from the syn- new direction was Paracelsus, who, in 1537, coined thethesis of the active ingredient; they are usually monitored famous phrase: Only the dose makes the poison according to the guidelines of the ICH (International (dosis sola facit venenum). Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and The way to organic synthetic drugsthe pharmacopoeias. The emergence of organic chemistry at the start of the 19th century brought progress, the importance of whichPharmacopoeias to ensure the safety of drugs can hardly be overestimated. Whereas previously treat-Specifications and test methods for the commonly used ment with drugs had been restricted largely to naturalactive ingredients and excipients are monographed in substances and inorganic chemicals, people now starteddetail in national pharmacopoeias in more than 38 states specifically to produce organic synthetic drugs, usingaccording to the World Health Organization (WHO). They substances isolated from medicinal plants as the basis. include the United States Pharmacopeia (USP), the An unprecedented advance in pharmaceutical synthesisEuropean Pharmacopoeia (Ph.Eur.), which emerged from led within a very short time to a vast number of synthe-the harmonization of the regulations of a number of sized active ingredients. In this context, researchers in-individual states, and the Japanese Pharmacopoeia (JP), creasingly succeeded in establishing a relationship be- to name but a few. The pharmacopoeias are official com- tween the action of these substances and their chemical pendia and contain the statutory requirements regarding structure.the identity, content, quality, purity, packaging, storage and labeling for active pharmaceutical ingredients and other products used for therapeutic purposes, and are essential for anyone who wants to produce, test or mar- ket medicinal products. 5. 05Selected test methods andUSP-NF monographsMetrohm is the competent contact for all matters con- and monographs of the USP. The National Formulary (NF)cerning chemical-pharmaceutical analysis and the valida-is the official compendium of standards for excipientstion of analytical methods. Apart from complying with and plant-based drugs.numerous official guidelines, Metrohm instruments andapplications satisfy the test methods for quality control Structure of the USP-NFand product release that are listed in the most important Apart from the description of numerous analytical meth-pharmacopoeias. ods in the general section of the USP-NF, the main sectioncontains generally applicable standards for active ingredi-In accordance with the harmonization efforts of the Phar- ents (USP) and excipients (NF) in the form of monographs.macopoeial Discussion Group (PDG), the present bro- More recent texts (since 1997) also contain a list of pos-chure, taking the place of the pharmacopeias not men- sible impurities (transparency list) that can be determinedtioned here, relates primarily to selected test methods with the test methods described.Test methods referenced in USP-NF monographs (USP 32-NF 27)ParameterUSP monographNumber of citations in the monographsTest methodPageIn 1328 USP monographspH value USPpH measurement6In 68 NF monographsConductivity USP Ultrapure water for pharmaceutical use Conductivity measurement6Various active ingredientsIn 127 USP monographs USPTitration 7-9Various excipientsIn 51 NF monographs USP In 616 USP monographsWater contentKarl Fischer Titration 10-11 Method I In 98 NF monographsVarious active ingredientsIn 27 USP monographs USP/USPIon chromatography 16-17Various excipientsIn 3 NF monographsVarious active ingredients USP In 8 USP monographsPolarography 18-19Determination ofThimerosal USPPolarography19antimicrobioticspH value, conductivity andparameters that can be Process-dependent Various Process analysis 20-21determined by titrationspecicationsand voltammetry 6. 06 Water for pharmaceutical use (water for injection) pH value Conductivity measuring cell (stainless steel) with The 867 pH Module provides all that is needed for meas-Pt 1000 uring the pH value according to USP. With 840 This measuring cell was developed especially for measure-TM Touch Control, PC Control or tiamo full, intelligent ment in waters with very low conductivity. The robust sensors and five-point calibration it meets the require- and easy-to-clean stainless steel construction is ideally ments of FDA regulation 21 CFR Part 11. In conjunction suited for conductivity values