Pharmaceutical industry
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SHIMADZU Excellence in Science

2. Pharmaceutical industry 2.1. TOC determination in ultrapure water – comparison of the various oxidation techniques 2.2. TOC determination in cleaning validation – final Rinse 2.3. TOC determination in cleaning validation – SWAB Method 2.4. TOC determination according to EP 2.2.44 2.5. TOC determination in ultra pure water with wet chemical oxidation 2.6. TOC determination according to USP 643 (USP 36-NF 31) Pharmaceutics is an ancient science that has supported people with remedies to help alleviate pain and heal illnesses. After medication, certain substances are expected to unfold...

SHIMADZUExcellence in Science Application News NO. SCA-130-201 Sum parameter - Total Organic Carbon Ultrapure water is one of the most widely used excipients in the production of pharmaceuticals. It is also used for cleaning purposes. Different application areas require different grades of ultrapure water quality. These grades are defined in the European Pharmacopoeia, which distinguishes between ‘Purified Water’, ‘Highly Purified Water’ and ‘Water for Injection’ (‘The United States Pharmacopoeia, however, does not use the same classification as the European Pharmacopoeia’). Water for...

The integrated ISP sample preparation unit (an 8-position switching valve with syringe and sparging gas connection) considerably reduces the users’ workload, as the instrument carries out dilution, acidification and sparging fully automatically. Fig. NPOC- Calibration (Blank and 500|jg/L) When using the high sensitivity catalyst, the detection limit is approximately 4jg/L. In addition, the combustion technique can be used in combination with the TNM-L module, whereby a single injection is sufficient for simultaneous determination of the total bound nitrogen. Simultaneous...

SHIMADZUExcellence in Science Application News NO. SCA-130-202 Sum parameter - Total Organic Carbon The highest purity and most careful handling of substances and active ingredients is an important requirement in the manufacture of pharmaceuticals. An effective removal of production residues in pharmaceutical plants is an essential precondition. A well-cleaned pharmaceutical production system prevents contamination and, consequently, the adulteration of the produced drug. This is particularly important in the production of active ingredients in batch processes, as the system is used for...

The TOC-Lcph employs the proven catalytic oxidation at 680 °C. The integrated sample preparation (ISP) module greatly reduces the users’ workload, as the instrument automatically carries out the dilution, acidification and degassing steps. For users who prefer wet-chemical oxidation for the determination of TOC, the TOC-Vwp analyzer with its various options, is available. The key technique of the TOC-Vwpanalyzer is the powerful oxidation via the combination of sodium persulfate and UV oxidation at 80°C. Practical Example: ■ Instrument / Measurement parameter Unit: TOC-Lcph Catalyst:...

SHIMADZU Excellence in Science Sum parameter - Total Organic Carbon TOC -Determination in cleaning validation - swab method Application News NO. SCA-130-203 Cleaning validation substantiates the effectiveness of a cleaning process and ensures that no residues remain on the surfaces of the production equipment. For the detection of contaminations, validated analytical methods must be used that are sensitive enough to determine the defined acceptable residue level. In general, residue limits of 10 ppm or 1/1000 of the usual therapeutic dose of an active substance are used as acceptance...

There, all carbon compounds are oxidized to CO2. To ensure complete oxidation, there is an additional catalyst in the combustion tube. The resulting CO2 is then transported to the detector in the main instrument. The NDIR detector of the TOC-L series contains a tandem cell that consists of a long cell (200 mm) and a short cell (1 mm). By default, the long cell is used for water analysis and the short cell for solid-sample analysis. To attain a higher sensitivity for the analysis of solids, the solid-sample module can also be connected to the long, and thus the more sensitive, measuring...

Sum parameter – Total Organic Carbon SCA-130-204 Since the USP (United States Pharmacopoeia) regulations for the determination of Aqua Purificata and Aqua ad injectabilia has been implemented into the European Pharmacopoeia (EP), TOC analysis has become increasingly established in quality control. Users who test the TOC content in pharmaceutical water must regularly test their TOC system using a system suitability test according to the method described in the EP 2.2.44 guidelines. ■ System suitability test For the system suitability test, a standard sucrose solution with a carbon content of...

■ TOC-Control L software The TOC-Control L software simplifies the implementation of the system suitability tests using integrated templates for the creation of calibration curves and the measurement of the control sample. The following figure shows an example of an EP calibration curve (2 points, blank and 500 The determination of benzoquinone is set in the sample / method properties wizard. After measuring the benzoquinone sample, the software automatically calculates the recovery according to EP 2.2.44, whereby the peak area values for the blank sample and the sucrose sample are obtained...

SHIMADZUExcellence in Science Application News NO. SCA-130-205 Sum parameter - Total Organic Carbon The quality of ultra pure water is of crucial significance in a large number of application areas such as monitoring of water quality in water treatment plants, and in industries such as chip manufacture or pharmaceutical production. Determination of Total Organic Carbon (TOC) is playing an increasingly important role in quality control. The TOC value indicates whether ultra pure water still contains any organic contaminants. TOC determination is fast and accurate and is defined in the...