pharmaceutical pill bottles next to iraman spectrometer blended with chemistry formula

Quantitative Raman

Raman spectroscopy has excellent specificity and selectivity which makes it an effective tool for both nondestructive qualitative identification and quantitative analysis. The Raman signal intensity is proportional to the number of molecules in a sample, determining the quantity within a given sample.

Quantitative Raman is applicable to measurements made for all types of samples, as part of a full material characterization. The functions can determine the composition of a mixture or blend, verify a product contains the correct concentration of ingredients, and detect impurities in samples. Raman is also utilized for reaction monitoring, giving quantitative results and trends for the formation of chemical species (product) and starting material consumption.

In the pharmaceutical industry Raman is used in quantitating active substances in pharmaceutical formulations and finished products (content uniformity), measuring crystallinity, and quantifying the concentration of different polymorphic forms. Active pharmaceutical ingredients (APIs) are predisposition to present materials with very strong Raman signals (while excipients and fillers are not always "strong" Raman scatterers) the concentration change of the API can be detected and a calibration model of the signal in conjunction with the concentration can be developed. It is important to measure the quantitative measurement of APIs in pharmaceutical products in order to verify the quality, safety and authenticity of drug products. Raman can be used to quantitatively measure the level of APIs, and give content uniformity of solid dosage forms.

Raman spectroscopy has the advantage of being able to make measurements on solid samples directly, or through transparent materials, for example products in blister packs or formulations in glass vials. With a Raman spectrum including information about the full samples matrix measured, it can be used for multicomponent analysis from a single measurement.


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Application Notes

Content uniformity (CU) testing is a crucial task in pharmaceutical manufacturing, as it ensures that each product that reaches a consumer contains a safe dosage of the active pharmaceutical ingredient (API). Transmission Raman spectroscopy is quickly emerging as a valued technique for CU testing due to its high chemical specificity with complex pharmaceutical formulations that contain multiple components.
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Raman is a well-developed spectroscopic tool for molecular identification and is widely accepted for qualitative analysis where it can provide rapid identification of materials, often at their point of use or delivery. Due to the high resolution that Raman can provide, it is also used for structural elucidation as well as quantitative analysis
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Raman spectroscopy is a well-suited spectroscopic technique for process development and control within development laboratories in chemical, pharmaceutical and other industries. This article demonstrates the utility of portable Raman spectroscopy as a simple and versatile tool for process analytical technology (PAT) in regards to raw material identification, in-situ monitoring of reactions in developing active pharmaceutical ingredients (APIs), and for real-time process monitoring.
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In this application note, we present the quantification of the concentration of urea in ethanol by Raman Spectroscopy and we show how this method can be employed for determining the percentage of urea in a solid inclusion compound with stearic acid.
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Over the past several years, an alarming trend has become evident, highlighting serious issues related to contaminated alcohol within the European Union. In September 2012 the Czech Republic officially banned the sale of hard liquor after 20 people died from the consumption of methanol-laced spirits. After an exhaustive study, the Czech Republic turned to the use of portable Raman spectroscopy to quantify methanol in contaminated spirits.
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Edible oils are not only a major source of nutrition but also a key basic material in the food industry. Vegetable oils are increasingly important because of their high content in mono- and polyunsaturated fatty acids in comparison with animal fats. In this application note, the main ingredients of olive oil, camellia oil, arachis oil, sunflower seed oil, and colza oil are analyzed using a portable Raman spectrometer combined with chemometrics software from B&W Tek.
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In this app note, acetaminophen is used to demonstrate the capability of the QTRam compact transmission Raman analyzer to quantify low concentrations of API in compressed tablets.
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Raman spectroscopy is a valuable technique for process analytical technology (PAT) in the pharmaceutical industry due to its capacity for non-destructive, real-time measurements, as well as its ability to be implemented for online and inline monitoring. In this application note, we’ll demonstrate the feasibility of monitoring glucose and lactate in a dynamic system using B&W Tek’s PTRam process development Raman analyzer.
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