Scholarlink

<p>Cardiovascular diseases remain a major healthcare challenge. â-Blockers such as propranolol play a critical role in their treatment. The quality and safety of pharmaceuticals directly depend on impurity control, which necessitates the use of reference standards. This work presents an approach to the development and standardization of a reference standard for the propranolol impurity (<i>RS</i>)-3-(naphthalen-1-yloxy)propane-1,2-diol (Impurity A). The methods of synthesis, purification, and analysis are described. Standardization pathways to ensure compliance with regulatory requirements are proposed. Material standardization for authenticity was performed using IR spectroscopy and mass spectrometry. The mass fraction of the main substance in the sample determined by the mass balance method was 99.124%.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Development and Standardization of a Reference Standard for the Propranolol Impurity (RS)-3-(Naphthalen-1-yloxy)Propane-1,2-diol (Impurity A) for Quality Control of Pharmaceuticals

  • 期刊论文

  • 发表日期：

    2025年6月1日

查看全文
  • N. A. Shul’ga,
  • V. I. Gegechkori,
  • M. O. Belyavsky,
  • S. Kordi

摘要

Cardiovascular diseases remain a major healthcare challenge. â-Blockers such as propranolol play a critical role in their treatment. The quality and safety of pharmaceuticals directly depend on impurity control, which necessitates the use of reference standards. This work presents an approach to the development and standardization of a reference standard for the propranolol impurity (RS)-3-(naphthalen-1-yloxy)propane-1,2-diol (Impurity A). The methods of synthesis, purification, and analysis are described. Standardization pathways to ensure compliance with regulatory requirements are proposed. Material standardization for authenticity was performed using IR spectroscopy and mass spectrometry. The mass fraction of the main substance in the sample determined by the mass balance method was 99.124%.