New JP Draft 2.28 Circular Dichroism Spectroscopy Published for Public Comments

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26-28 October 2021

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The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published a Japanese Pharmacopoeia (JP) draft of a New General Test 2.28 Circular Dichroism Spectroscopy.

The chapter starts with a short introduction to the topic and an explanation of the relevant equations and definitions. The method is defined as follows:

The circular dichroism spectroscopy is a method used to analyze and determine the structure of optically active substances, discriminate active substances from enantiomers, diastereomers, etc by using the phenomenon (circular dichroism) in which the degrees of absorption of left and right circularly polarized lights differ in the absorption wave length region of active substances.

After the general introduction, the new chapter is divided into the following chapters and subchapters:

• 1. Apparatus
• 2. Methods
  2.1. Identification test
  2.2. Analysis of secondary structure
• 3. Verification of the performance of apparatus
  3.1. Accuracy of circular dichroism
  3.2. Linearity of modulation

The draft document is available as a PDF file on the PMDA's website. Comments can be submitted until September 30, 2021. For this purpose, a form for comments has to be downloaded and sent by e-mail after it has been filled in.