ResourceSpectroscopy

Using Near-Infrared Spectroscopy in Compliance with Pharma Regulations

24 Apr 2018

The pharmaceutical industry is unique with its extensive regulations. Hence, quality control is essential to ensure compliance with regulations and guidelines. In this white paper, Metrohm discusses the use of near-infrared spectroscopy (NIRS) for quality control and assurance of pharmaceutical products.

NIRS DS2500 Analyzer

Metrohm AG

With the compact NIRS DS2500, near-infrared analysis has taken yet another step into the future of routine analysis. This dedicated analyzer offers exceptional accuracy across a broad wavelength range of 400 to 2500 nm and is designed for routine analysis along the entire production chain. The predispersive Monochromator technology now being utilized in the NIRS DS2500 guarantees a high degree of versatility and stability across the entire spectral range from 400 to 2500 nm. With the maximum possible signal-noise ratio, the NIRS DS2500 simply performs, in less than one minute, analyses of both sophisticated and low-level parameters that must be very accurate. The NIRS DS2500 was created as a high-performance instrument for harsh production environments. Robust, easy-to-use and IP65 certified, it withstands humidity, dust, vibrations and temperature fluctuations.   NIRS DS2500 Analyzer Features: Compact analyzer for reflectance measurements Maximum optical performance across the entire wavelength range (400 - 2500 nm) Matching results, even in difficult environments Network-capable via LAN (local) or direct PC connection New predispersive Monochromator Optional sampling accessories

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Near Infrared SpectroscopyNear-infrared (NIR) spectroscopy measures the interaction of near-infrared light with a sample, including transmission, reflectance and absorbance, facilitating the identification of analytes. Measurements can be conducted using a Fourier-transform near infrared (FT-NIR) spectrometer, while there are also UV-Vis- NIR spectrophotometers that measure a broader spectrum of wavelengths. Find the best NIR spectroscopy products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Robotic InstrumentsRobotic instruments can be used for high-throughput automation of many lab processes. Such processes use instruments for assays like cell based assays and ELISA, for sample preparation like shakers, centrifuges and incubators, and for analysis such as sequencing and western blot analyzers. Useful features of robotic instruments include speed, reproducibility, barcode readers, software and automation.Robotic WorkstationsRobotic workstations are automated platforms enabling the user to perform high-throughput, multi-application processes, from sample preparation tasks such as PCR set-up, DNA purification and NGS library preparation, to integrated sample prep and analysis workstations. Automation makes processes consistent, fast, precise and fully walk-away. Find the best robotic workstations in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Software PlatformsSoftware platforms are useful for various stages of laboratory experiments from data collection to data storage and processing. For instance lab software is available for system control, data management, data analysis and qualification / validation.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Quality TestingQuality testing ensures that products meet required specifications and safety standards in various industries, including pharmaceuticals, food, and materials. It is essential for maintaining product quality and consumer safety. Explore quality testing tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.NIRSPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.
Using Near-Infrared Spectroscopy in Compliance with Pharma Regulations