제약 분야

Raman spectroscopy fulfils a critical analytical role at many stages of the pharmaceutical product design and production process. Applications range from monitoring and controlling large scale manufacturing processes, to profiling the distribution of active pharmaceutical ingredients (API) and excipients at different stages in a formulation cycle. Raman offers unparalleled polymorph discrimination, is capable of studying aqueous and solid samples, and is particularly suited to combining with other analytical techniques given that it provides non-destructive analysis requiring little or no sample preparation.

The illustration shows StreamLine™ Plus chemical images of a pharmaceutical tablet. The image of the complete tablet was collected in 4 minutes, with the image generated from greater than 10,000 individual spectra. The data sets were subsequently analysed using a chemometric technique to identify the three APIs. For more detail on this analysis, and further information on topics related such as high throughput screening (HTS), polymorph discrimination, FDA 21 FDA Part 11 compliance, please download the relevant document.

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Documents for download

	Polymorph discrimination using low wavenumber direct lattice information This application note demonstrates how Renishaw's NExT filter accessory and inVia Raman microscope can be applied to directly record polymorphic lattice information. The polymorphic discriminatory power is illustrated using different carbamazepine polymorphs as a real case example, where complex data interpretation is not required for unequivocal differentiation.	[258KB]
	Polymorph screening, differentiation, and distribution in the pharmaceutical industry This application note illustrates how Renishaw's inVia Raman microscope can help the pharmaceutical industry with high throughput screening (HTS), formulation, and pharmaceutical identification and characterisation.	[570KB]
	Polymorph identification and qualification using Renishaw's high throughput screening technology This technology note illustrates the benefits of combining dedicated analysis software with a high performance Raman instrument, and how Renishaw supplies an effective, user-friendly solution to provide complementary information to the multitude of established HTS techniques commercially available.	[608KB]
	Raman spectroscopy: next generation pharmaceutical applications One-page document detailing the use of rapid mapping, chemometric analysis, close-to-laser-line spectroscopy, and high-throughput screening.	[396KB]
	Raman spectroscopy of pharmaceuticals in a humidity and temperature controlled environment Application note illustrating the use sensitivity and suitability of Raman spectroscopy to variations in humidity	[274KB]
	Raman in the pharmaceutical industry One page document illustrating the use of Raman for particle distribution mapping, raw material identification, and polymorph identification	[816KB]
	Using Raman spectroscopy for polymorph differentiation and chemical imaging One page document describing two pharmaceutical applications of Raman spectroscopy and imaging.	[329KB]

Selected publications

Defining a strategy for chemical imaging of industrial pharmaceutical samples on Raman line-mapping and global illumination instruments (2006) Donald Clark et al, Applied Spectroscopy, 60, 494-502

Drug characterization in low dosage pharmaceutical tablets using Raman microscopic mapping (2006), Mark J. Henson et al, Applied Spectroscopy, 60, 11, 1247-1255

A comparison of Raman chemical images produced by univariate and multivariate data processing—a simulation with an example from pharmaceutical practice (2004), Slobodan  a i  et al, Analyst, 129, 1001–1007

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