Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures (Ph. Eur. 11.0), the EDQM published some examples. The intention is to provide users with practical guidance on how critical factors potentially affecting the Analytical Procedure Performance Characteristics (APPCs) can be identified. However, it is emphasized, that the pre-requisite for the implementation of any analytical procedure is a suitable quality system, which ensures that the requirements set for personnel, premises, and equipment are fulfilled.

Examples for Critical Factor Assessment

The following six examples are provided for the assessment of critical factors associated with the analytical procedure under actual conditions:

  • Pharmaceutical ingredient (Mannitol) / Identification by infrared absorption spectrophotometry
  • Drug product (Deferiprone tablets) / Related substances test by LC-UV 
  • Active substance (Benzylpenicillin potassium) / Assay by LC-UV
  • Infliximab concentrated solution / Cell-based assay procedures
  • Drug Product (Deferiprone oral solution) / Microbial enumeration test
  • Active substance (Deferiprone) / Sulfated ash

More information is available in the Examples of implementation of pharmacopoeial procedures according to Chapter 5.26 "Implementation of pharmacopoeial procedures” published in Pharmeuropa Online under Technical Information.

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