These criteria vary depending upon the biological carrier and the active constituent of the drug, as well as the intended delivery method. The requirements of intravenous solutions vary greatly from those placed upon soluble capsules and tablets, for example. FTIR analyzers are commonly used to ensure that pharmaceuticals in various phases meet their pre-defined certifications.
An FTIR analyzer uses modulated infrared light to generate an interferogram of a chemical sample. These interferograms are converted into a spectrum using a Fourier Transform algorithm. With knowledge of the chemical compounds, models are developed to measure concentration as low as the ultra-trace level to assess multiple characteristics and properties of a given material. This highly-precise quantitative method has been ubiquitously used in academic applications and is increasingly applied to industrial processes such as pharmaceutical quality control.
The MB3000 and MB3600 are ABB’s most robust FTIR analyzers for laboratory applications, representing the optimal intersection between high reliability and low ownership cost. These instruments were engineered to overcome the apparent contradiction between quality requirements and pharmaceutical profitability by combining a low-footprint design with high modularity for the performance of multi-sample types analysis in pharmaceutical quality control.
The MB3000-PH can measure a spectral range of 485 – 8,500 wavenumbers (cm-1), enabling precise photometric analysis of samples at a resolution of 0.7 cm-1. Default variants of the MB3000-PH FTIR analyzer are equipped with HORIZON MBTM software and its powerful search engine for rapid data searches across a broad range of spectral comparisons. The Security Module complies with the CFR21 P11 requirements of pharmacopeia guidelines.
The MIRacleTM accessory enables the FTIR analyzer to acquire the attenuated total reflection (ATR) of common formulations, including liquids, pastes, and gels for enhanced assessment of various sample types available on the market.
The MB3600-PH, operating in the Near Infrared, as the same characteristics that the MB3000 but with a spectral range of 3,700 – 14,885 wavenumbers (cm-1). Benefitting from the same HORIZON MBTM software module performances, the package also comes with a specific module for model developments required for QA/QC specific needs.
The HORIZON QATM software, specifically designed for the pharmaceutical market, provides a new benchmark for pharmaceutical testing via FTIR analysis. With the ease-of-use expected from such software, and the unmatched precision and reliability of the analyzer, the results can be used to ensure batch-to-batch consistency and eliminate bad-batches from circulation.
ABB supplies an extensive portfolio of FTIR analyzers for laboratory applications, with a range of additional accessories to enhance the measuring capacities of our existing instruments. We provide apparatuses for the analysis of raw materials, active ingredients, and polymeric containers such as PET bottles and preforms. These products can be used for the most robust quality control of pharmaceuticals currently available.
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