![]() ![]() Pre-Programmed Blank Valueīecause of the good reproducibility of this data, the blank value for each method is programed directly into Merck´s Spectroquant® NOVA and Pharo photometers. The lower limit of detection is equal to the concentration of the blank the method detection limit is the lowest measurement value that is statistically different from the blank value and represents the lowest measurable value. In addition to the characteristics such as confidence level, standard deviation and variation coefficient, which are created according to ISO 8466-1, the lower limit of detection and the method detection limit values are of particular importance. The quality data also provides a comparison that the auditor can use to judge the accuracy of the results obtained in the customer´s laboratory when using a Spectroquant® test kit. This offers the user clear information about the manufacturing accuracy achieved by Merck and indicates long-term quality our customers can rely on. To develop each of the above listed statistics, data is averaged from several batches. Number of production batches used to create the certificate of quality.Confidence interval with 95 percent probability.It offers the user a quick overview of all relevant quality data and can be downloaded on each product page. Your Document for Consistently High Product QualityĮach Spectroquant® test kit comes with our quality certificate. Brand comparisons confirm the advantages of EMSURE® reagents.Quality Certificates in Spectroquant® Test Kits ![]() Clearly, EMSURE® not only fulfills international guidelines, but surpasses them by far. those required by regulatory organizations (ACS, Reag. ![]() The number of parameters specified for EMSURE® products vs. All EMSURE® products with the designation “ISO” are compliant with ISO 6353. Specifically, ISO 6353 defines the requirements for reagents used in analytical chemistry. International Organization for Standardization (ISO)īesides pharmacopoeia regulations, the International Organization for Standardization (ISO) also sets guidelines for analytical reagents. It contains a detailed section describing how reagents are to be used for analysis in accordance with the European Pharmacopoeia. Ph Eur defines requirements for the “qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production”. Ph Eur” and fulfill the requirements of the European Pharmacopoeia (Ph Eur) published by the European Directorate for the Quality of Medicines & Health Care (EDQM). Most EMSURE® products bear the designation “Reag. Reagents Section of the European Pharmacopoeia (Reag. Our in-depth approach to ACS specifications includes comparison with our own stringent quality control standards. We always follow the most recent edition of the guidelines and regularly check for updates. This is essential as it enables the use of new, more sensitive technologies.Īll EMPARTA® and most EMSURE® products are specified according to the monographs published in the “Reagent Chemicals” guidelines of the American Chemical Society (ACS). We are regularly adding new parameters and improving our specifications as required by our customers. Ph Eur, and ISO guidelines but exceed them – not only by the number of specified parameters but also by lower limiting values. Most EMSURE® specifications not only fulfill ACS, Reag. This way, we make sure their specifications suit the regulatory environment you work in. MilliporeSigma’s analytical reagents are specified in accordance with various international regulations depending on their quality grade. ![]()
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