2018
DOI: 10.1016/j.jpba.2018.04.008
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Quantifying low levels (<0.5% w/w) of warfarin sodium salts in oral solid dose forms using Transmission Raman spectroscopy

Abstract: In this feasibility study Transmission Raman spectroscopy (TRS) has been used to build quantitative models for warfarin sodium and warfarin sodium clathrate. The type of warfarin present in manufactured tablets may affect product quality. Models were used to predict warfarin sodium in commercially available tablets at extremely low dosage levels (0.5% w/w). The laboratory made calibration samples used in the modelling varied in amorphous sodium, crystalline clathrate warfarin forms, excipients and dye. This ap… Show more

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Cited by 18 publications
(6 citation statements)
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“…There exist several instrumental configurations to address this point, for example, applying an imaging technique by means of a multi‐spot detection geometry. [ 64 ] A different approach has been presented by Griffen et al [ 65 ] who used transmission Raman spectroscopy to obtain chemically specific information of large sampling volumes from solid samples in tablet form. In both cases, data analysis by means of multivariate statistics enabled to achieve detection limits of the respective target substances of less than 1 g/kg.…”
Section: Resultsmentioning
confidence: 99%
“…There exist several instrumental configurations to address this point, for example, applying an imaging technique by means of a multi‐spot detection geometry. [ 64 ] A different approach has been presented by Griffen et al [ 65 ] who used transmission Raman spectroscopy to obtain chemically specific information of large sampling volumes from solid samples in tablet form. In both cases, data analysis by means of multivariate statistics enabled to achieve detection limits of the respective target substances of less than 1 g/kg.…”
Section: Resultsmentioning
confidence: 99%
“…for drug sensing [33][34][35][36][37][38][39] in forensics [28,29,31,40] and in the pharmaceutical industry [32]. For example, transmission Raman-based methods enable at-line or on-line analysis of bulk content of tablets [41][42][43] or active pharmaceutical ingredients (APIs) of other solid dosage forms [44]. This technique reached a high level of applicability [44]: cost-savings have been demonstrated in real-world use [45], and considerations for regulatory submission are being discussed [46] for pharmaceutical applications.…”
Section: Introductionmentioning
confidence: 99%
“…For example, transmission Raman-based methods enable at-line or on-line analysis of bulk content of tablets [41][42][43] or active pharmaceutical ingredients (APIs) of other solid dosage forms [44]. This technique reached a high level of applicability [44]: cost-savings have been demonstrated in real-world use [45], and considerations for regulatory submission are being discussed [46] for pharmaceutical applications. However, conventional Raman scattering is a very weak process, limiting its use in on-site and point-of-care applications.…”
Section: Introductionmentioning
confidence: 99%
“…Transmission Raman spectroscopy (TRS) is an emerging technique, capable of quantitative analysis of API in drug products. 14 It is nondestructive, therefore no sample preparation and consumables are needed, which provides cost-effective and environmentally friendly opportunities for in-line, on-line, and off-line applications. In addition, it does not require extensive training to operate, and the routine sample analysis is rapid.…”
Section: Introductionmentioning
confidence: 99%