Diazotization titrations in pharmacopoeial quality control of medicines and proposals for their revision in the European Pharmacopoeia

Ceska Slov Farm. 2023 Fall;72(4):165-171.

Abstract

Based on the data in the Ph. Eur., some other newer pharmacopoeias and published experimental papers propose to revise the text of Ph. Eur. 2.5.8. First, it is necessary to specify which of the electrometric methods should be used to indicate the endpoint of diazotization titrations in Ph. Eur. (preferable potentiometry with a platinum indicating electrode). The amount of potassium bromide in the titration solution may be reduced to 1 g, the cooling of the solution before titration may be omitted from the framework procedure, and it may be specified in individual monographs if necessary to obtain accurate and correct results for some medicines. Diazotization titration can be performed in Ph. Eur. and can also be used to determine the content of some other medicines.

Keywords: titration of medicines with sodium nitrite • end-point indication • other conditions • Ph. Eur..

MeSH terms

  • Europe
  • Potentiometry* / methods
  • Quality Control*

Substances

  • potassium bromide