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Pharmaceutical testing – high quality results the easy way!

publication date: Apr 28, 2014
 | 
author/source: Metrohm AG

Many parameters in a single analysis

NIRSystemsNear-infrared spectroscopy (NIRS) offers numerous advantages over many wet-chemical analytical methods. A diverse range of parameters can be determined simultaneously with just one analysis. Metrohm NIRSystems are economical and fast, enabling qualitative and quantitative analyses that are noninvasive and nondestructive.

NIRS is an indispensable analysis technique that can be used along the entire production chain – from incoming materials to processing to the quality control of finished products. NIRS meets the requirements of numerous international pharmacopoeias, e.g., USP, Ph. Eur., and JP.

NIRS – the fast solution for every sample matrix

Near-infrared spectroscopy requires no sample preparation and can handle any sample matrix, no matter if it is:

  • powders or granulates
  • tablets or capsules
  • creams or gels
  • solutions or suspensions
  • polymer films
  • freeze-dried samples

 

NIRS – screening through packaged materials

NIRS can even perform determinations on contents sealed in transparent packaging such as glass and films. This is particularly appealing for incoming goods inspections and packaged end products. Handling could not be easier; in fact, it is so easy that NIRS can be used directly in pharmacies and customs offices.

Nondestructive analysis technique

NIRS has long been one of the most important and versatile analytical techniques in the pharmaceutical industry – and not just because everybody in the pharma industry is talking about PAT and QbD. The decisive benefit of NIRS is the possibility of obtaining reliable analysis results in just seconds without any sample preparation or reagents whatsoever.

PAT and QbD – with NIRS in search of the best of all methods

Drug manufacturing is undergoing a transformation. The FDA's stated goal is to cut development time for new drugs while at the same time significantly improving quality. This requirement can only be fulfilled with analytical techniques which monitor the entire process – from incoming raw materials to the final inspection. To achieve that, perfect PAT sensors are needed that enable "live" tracking of the manufacturing process. NIRS is the technique that makes this possible. An inline sensor monitors product quality in real time. This prevents charges related to rejected products and reduces overall costs.

In accordance with international pharmacopoeias

 As a secondary test method, NIRS is recommended in all of the key pharmacopoeias – from the European (Ph.Eur.2.2.40) to the American (USP<1119>) to the Japanese pharmacopoeia. All of Metrohm's NIRSystems instruments meet the standards for wavelength precision, reproducibility, and photometric noise. Numerous reference standards and user-friendly software make it easy to check the instrument requirements specified in the pharmacopoeias. The pharmaceutical version of the Vision software is fully validated and compliant with 21 CFR Part 11. Metrohm NIRSystems also offers complete IQ/OQ documentation and instrument performance certification (IPC). Documented parameters guarantee that the instrument performs properly.


more about Metrohm NIRSystems


download the latest applications developed by Metrohm


Order our guide to near-infrared spectroscopic analysis of industrial manufacturing processes free of charge


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