Manufacturing & QA / Spectroscopy & Elemental Analysis

Applications for Spectroscopy & Elemental Analysis


Contaminant Analysis on Tablet Surface Using the IRSpirit

The Shimadzu IRSpirit is a compact FTIR with a footprint approximately the size of an A3
(11 × 17 in) sheet of paper. Designed to take up little space, the sample compartment of the IRSpirit is easily accessible whether installed in "landscape" or "portrait" orientation, so that even a narrow opening on a lab bench can accommodate it. The performance it provides is remarkable too, with the highest signal to noise ratio and maximum resolution in its class. These high-level specifications translate into robust results, especially considering its small footprint. Shimadzu realizes that customers need access to a wide variety of sampling accessories to get the most out of their FTIR. The sampling compartment of the IRSpirit, designed for maximum flexibility, accommodates existing Shimadzu and third party accessories such as ATR and diffuse reflectance, as well as transmission accessories such as a KBr pellet holder and demountable cells.


ICH Q3D Elemental Impurities Analysis of Tablets by EDX

In the United States, the United States Pharmacopoeia General Test Chapters USP <232> and <233> have been applied to new drug products since January 1, 2018. ICP-MS and ICP-AES are recommended as the analysis procedures in the chapters. However, if the validation requirements are met, the alternative procedure can be substituted for the recommended analysis procedures. Therefore, the appropriateness of Energy Dispersive X-ray Fluorescence Spectrometer was verified referring to “Limit Procedures” in USP <233>*1. The used instrument was EDX-7000 and the test was conducted by evaluating of elemental impurities in oral drug (tablets). As the target concentration (allowable concentration), the value obtained by dividing 30% of the PDE *2 value by the maximum daily dose was set.

*1 Since the measurement sample in EDX is ’’Powder’’, the ’’Solution’’ part described in the test method was replaced with 'powder'

*2 PDE: Permitted Daily Exposure


Elution Evaluation of Silver Compound containing Antibacterial Fabric by AAS

With the coronavirus (COVID-19) epidemic, silver ions (Ag+) are drawing attention again. Because of their high antibacterial properties, harmlessness to humans, and long-lasting antibacterial effects, silver compounds are widely used as inorganic antibacterial agents, and many daily necessities with added silver are commercially available. Previous studies have confirmed that Ag+ has antibacterial effects against the influenza virus, common coronavirus, MRSA, etc. Herein, we introduce an example of evaluating the elution volume of silver (Ag) from an antibacterial fabric containing silver compound using the atomic absorption method. By using both the frame method, which enables rapid measurement, and the highly sensitive furnace method, it is possible to analyze eluted Ag in a wide concentration range.+

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