AI Article Synopsis

  • The paper outlines a method for using near-infrared diffuse reflectance spectroscopy to identify and quantify ranitidine in various pharmaceutical forms using a fiber optic probe.
  • This method was developed for routine use in the pharmaceutical industry to replace traditional reference methods and has been approved by the National Medicine Regulatory Agency (Infarmed).
  • The authors view this as an initial step towards a broader approach to the parametric release of pharmaceutical products.

Article Abstract

In this paper we describe the strategy used in the development and validation of a near-infrared diffuse reflectance spectroscopy method for identification and quantification of ranitidine in pharmaceutical products (granulates, cores and coated tablets) at-line, with a fiber optic probe. This method was developed in a pharmaceutical industry for routine application, to replace reference methods and was submitted and approved to the National Medicine Regulatory Agency (Infarmed). We consider that this is the first step of a broader parametric release approach to pharmaceutical products.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.talanta.2007.12.008DOI Listing

Publication Analysis

Top Keywords

pharmaceutical products
12
development validation
8
ranitidine pharmaceutical
8
reflectance spectroscopy
8
parametric release
8
release approach
8
validation method
4
method active
4
active drug
4
drug identification
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!