Pharmaceutical analysis – Quality control of pharmaceuticals
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Pharmaceutical analysis Quality control of pharmaceuticals

Metrohm ... • is the global market leader in titration • offers a complete portfolio for NIR and Raman analysis, in addition to all of the methods of • ion analysis – 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 anion chromatography • provides you with unparalleled application expertise • offers you more than 1800 applications free of charge • supports you with dependable on-site service worldwide • is not listed on the stock exchange,...

Metrohm – customized analysis for the pharmaceutical industry The high standards of approval authorities Authorities around the globe hold the pharmaceutical industry to very high standards of drug quality and safety. The standards are documented in official collections of recognized pharmaceutical rules in pharmacopoeias. They provide a legal consumer protection framework for ensuring that drugs are used safely. Measurement and testing procedures used in the context of drug testing identify drugs and determine whether they can be released. Reliable instruments and methods are required to...

Chemical pharmaceutical analysis 04 The history of pharmacology The search for medicines is nearly as old as humanity itself. Documentary evidence exists to show that active pharmaceutical ingredients from plant, mineral, and animal sources were already being used for medicinal purposes by the earliest advanced civilizations (China, India, Mesopotamia and Egypt). Systematic descriptions of medicines have been handed down to us from Greek antiquity (Hippocrates, Theophrastus) and from the Roman Empire (Dioscorides, Galen). This knowledge was adopted and further developed by Arab scholars...

Test methods, tests, and USP-NF monographs Applications in accordance with pharmacopoeias Metrohm is your qualified partner for all chemical-pharmaceutical analysis issues and for analytical methods validation. In addition to their compliance with official directives, Metrohm instruments and applications comply with many of the quality control and product approval test methods cited in pharmacopoeias. Structure of the USP-NF Four chapters form the backbone of the USP-NF. One chapter provides the analytical tools of the pharmacopoeia with a detailed description of test methods and tests....

Water for pharmaceutical use (water for injection) pH value The 867 pH Module provides everything you need to measure the pH value according to USP<791>: it meets the requirements of FDA Regulation 21 CFR Part 11 thanks to either 900 Touch Control or tiamo full software. An electrode test can be performed in conjunction with tiamo or 900 Touch Control. Conductivity and pH value can be measured in the same vessel when the 856 Conductivity Module is combined with the 867 pH Module. Conductivity Particularly strict regulations apply to the measurement of the conductivity of water for...

Application know-how from the experts Because of their simplicity and accuracy, titration methods are used for a large proportion of the content determinations described in the monographs, for example in accordance with USP<541>. Taking into account the latest methodological findings, Metrohm has developed hundreds of titration methods with Metrosensors based on the U.S. Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.). Some older USP methods are still based on high sample weights with a titrant consumption of up to 50 mL. Based on Ph. Eur., Metrohm has reduced the sample weights...

Titrando – the smart titrator with comprehensive security 08 Thanks to its modular design, the Titrando System can be optimally adapted to any application. Both as a standalone titrator and in combination with the 900 Touch Control or tiamo, it is in compliance with FDA Regulation 21 CFR Part 11. Certified and smart dosing elements Metrohm dosing elements set new standards in reliability. An inconspicuous data chip contains all the data that the Titrando needs to perform titrations, i.e., serial number, cylinder number, type of reagent, titer, last titer determination, shelf-life data, and...

tiamo – titration and more tiamo is the leader in control and database software, not only for titrators and dosing devices, but also for total laboratory automation that includes the client/ server system. The name tiamo stands for "titration and more" – tiamo can do more than just titrate. tiamo is a titration network (NTDS = Networked Titration Data System). • tiamo guarantees data security Whether you need to satisfy GMP or GLP rules, regulations regarding the security of electronic data, or traceability requirement for results in accordance with the FDA’s Regulation 21 CFR Part 11,...

Automatic nonaqueous titration with the MATi 03 10 Enormous time savings and results that are more accurate and precise are the crucial benefits of automation. The MATi 03 (Metrohm Automated Titration) is specially designed for nonaqueous titrations in the pharmaceutical industry – both potentiometric and photometric. Series of up to 59 samples can be accommodated on the 815 Robotic USB Sample Processor XL. tiamo is responsible for all of the controls. The system is noteworthy for its high resistance to organic solvents. The MATi 03 with 815 Robotic USB Sample Processor XL (left) and 907...

Photometric titrations with the Optrode Maximum precision Titrations using color indicators are still widely used in pharmacopoeias (chelatometry/complexometry), but when performed manually, the results depend, quite literally, on the eye of the beholder. The new Optrode makes it possible to replace this subjective determination of the equivalence point with an objective process that is completely independent of the human eye. Its eight wavelengths, ranging from 470 to 660 nm, cover a broad spectrum of color indicators. The great advantage of this is that the chemistry does not change –...