Analysis of raw materials

In the production of active pharmaceutical ingredients and drug, if the impurity in the raw materials and dopant infiltrated, may be a potential threat to the health of the patient.These impurities and dopant also may lead to the decline in output and increase the demand of the product purification.Therefore, for the pharmaceutical industry, identification and quantitative analysis of impurities in raw materials into the factory and dopant is indispensable.This can not only guarantee the safety and quality of medicines, also can ensure production run smoothly, improve the cost efficiency.

Brooke can provide comprehensive analysis instrument combination, for fast and accurate identification of raw materials.

Even if the low concentration of impurities to (the) PPM level, X-ray fluorescence (XRF) technology can still be accurate in a wide variety of pharmaceutical raw materials to capture the inorganic impurities.XRF can quickly identify a particular substance, such as the distinction between potassium chloride and sodium chloride.High-end laboratory level energy dispersive XRF spectrometer with high flux, the advantages of easy operation, and comply with applicable data management, such as the United States food and drug administration issued the rules of the federal assembly (CFR) of chapter 11, paragraph 21.Portable XRF equipment can be used for the rapid assessment of raw materials to the factory.

Compared with the traditional wet chemical techniques, XRF is the main advantage of sample preparation is simple, operation difficulty is small, low operating cost (without toxic/expensive chemicals/gas).

X-ray diffraction (XRD) can directly detect solid arrangement of the atoms and molecules.Powder XRD, therefore, can be through the "fingerprint" detection, identification and quantitative analysis to crystal or amorphous active pharmaceutical ingredients, excipients and any other materials.By XRD can rapid screening of raw materials, in order to control the purity of the mixture, crystallinity, polycrystalline type and abundance of absolute phase.

Equipped with a optical fiber probe of Fourier transform near infrared spectrum (NIR) with unprecedented speed and ultra high flexibility, to identify solid and liquid materials.As a result, the FT - NIR is rapidly become one of the standard methods of raw material analysis.

MPA II and MATRIX - F FT NIR spectrometer can match the optical fiber probe, and to analyze the raw material can be directly on the container.Not only can improve the identification software step by step guide users to establish a database, even in the loading dock can identify for raw materials for a key.MATRIX - F chassis to the national electrical manufacturers association (NEMA) regulation protection grade, in order to make sure it's in the factory of the worst environment can still run normally.

By using Fourier transform infrared spectrometer (FT IR), people usually use attenuated total reflection (ATR) technology into the factory to complete the inspection and quality control.ATR can get almost all types of samples in a few seconds (liquid, solid and paste), infrared spectrum.Just put the samples and spectrogram, comparing the reference standard spectra of raw materials can be completed through analysis to identify.

In view of the Raman spectroscopy is a powerful performance, thus portable Raman equipment requirements are also increasing in terms of material validation.Selective information without sample preparation, can through the transparent packaging directly measured materials, these advantages makes Raman spectrum analysis technology of choice for raw materials.

Brooke r&d BRAVO handheld Raman spectrometer breakthrough the limitations such as fluorescence, and security problems.As a class 1 m laser products, BRAVO combine user safety and use convenience, of course, completely in line with the United States food and drug administration issued the rules of the federal assembly (CFR) of chapter 21 paragraph 11 management specification.In the field of pharmaceutical industry, BRAVO validation lab is the apple of your materials.

Nuclear magnetic resonance (NMR), on the other hand, can not only provide abundant structural information, and in essence, it is a kind of quantitative techniques.NMR can therefore be in a single measurement (less than a minute) at the same time identify raw material composition and quantitative analysis.If detected impurities in the experiments, the NMR and mass spectrometry is characterization of unknown material of choice for technology.The test results of the two can decide whether or not a raw material through into the factory inspection.